Driving The Power of Innate and Adaptive Tumor Immunity

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About Us

Turnstone Biologics’ mission is to deliver breakthrough cancer immunotherapies by advancing two leading and complementary platforms targeting tumor immunity, to improve survival for people with cancer.

Turnstone Biologics is a privately-held clinical stage biotech company with offices in New York (USA) and Ottawa (Canada). Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity plus local expression of encoded therapeutics, while the TIL cell therapy platform leverages clinically validated protocols to add industry-leading cell selection strategies. Our development programs drive innate and adaptive tumor immunity to provide benefit to the millions of cancer patients underserved by current treatment options.

Our scientific founders, Drs. John Bell, David Stojdl and Brian Lichty, are world leaders in the oncology and immunotherapy fields. Collectively, they have authored more than 200 publications in leading journals, and have spent years engineering and developing technologies to create the next generation of powerful, targeted therapies for cancer patients.

Our passionate team of leaders in oncology have decades of experience in biotechnology, academia and pharmaceutical drug development. With comprehensive capabilities in immuno-oncology discovery, basic research, translation, clinical development, manufacturing, and commercialization, we are committed to bringing new medicines to people with cancer to improve their lives.

Our Science

Turnstone Biologics is focused on driving innate and adaptive tumor immunity through the development of two independent, yet complementary platforms, built on a foundation of validated clinical success.

Turnstone’s proprietary vaccinia virus platform has been engineered to stimulate the immune system, drive antigen presentation and recognition, and re-shape the tumor microenvironment. The high degree of tumor selectivity and large transgene capacity of the virus can be utilized to deliver other agents and therapeutics directly to sites of tumors throughout the body for local expression, reducing their potential for systemic toxicity.

There has been strong clinical evidence demonstrating the benefit of TIL therapy in solid tumors, however, driving clinical benefit in harder to treat, lower mutational burden cancer indications, is the next needed innovation in the field. Turnstone’s proprietary TIL platform combines leading methods for identifying relevant tumor reactive T cells from TILs with the latest advancements in cell sorting and cell rejuvenation, enabling rapid advancement of these highly promising enriched T cell therapies to address a broad range of solid tumors.

Pipeline

Turnstone is developing two highly innovative and complementary therapeutic platforms. Our RIVAL pipeline is derived from our viral immunotherapy platform, with the lead RIVAL-01 program in early clinical development. Our TIDAL pipeline is derived from our cell therapy platform, with the lead TIDAL-01 program expected to enter the clinic by the end of 2021.

 

Turnstone Biologics Pipeline

Leadership

Turnstone Biologics was founded by world-leading experts in cancer immunotherapies who have defined and advanced the field over the course of multiple decades. Our leadership team includes experts from academia and the life sciences industry who share the vision of bringing innovative immunotherapies based on our unique viral and TIL therapy platforms to people with cancer.

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Sammy Farah, Ph.D., M.B.A.

Sammy Farah, Ph.D., M.B.A.

President & Chief Executive Officer

Dr. Sammy Farah has extensive vaccine expertise and almost 20 years of scientific, business and executive management experience in the biotechnology industry. He joined Turnstone Biologics from Synthetic Genomics Vaccines, Inc., where he served as President. Prior to that, he was Chief Business Officer of Immune Design Corp. And before then, Sammy was at Versant Ventures where he specialized in biotechnology investing and new company formation, and at Merck & Co., Inc. where he led technology support for multiple commercial vaccine franchises before joining the business development and licensing group to evaluate and execute new external technology and research partnerships. Dr. Farah earned an M.B.A. from the Wharton School at the University of Pennsylvania, a Ph.D. in biochemical engineering from Stanford University, and a B.S. in biochemical engineering from the Massachusetts Institute of Technology.

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José Manuel Otero, Ph.D.

José Manuel Otero, Ph.D.

Chief Technology Officer

Dr. Otero heads bioprocess development, manufacturing, and CMC at Turnstone, across both viral and cell-based therapies, bringing with him nearly 20 years of industry experience in vaccines and complex biologics. He joined Turnstone from Seres Therapeutics, Inc., where he was Vice President of Bioprocess Development and Manufacturing. Dr. Otero oversaw expansion of the group and was the team leader for the first synthetic microbiome therapy to enter clinical studies in the U.S. Dr. Otero started his career at Merck & Co., Inc., where he was Head of Fermentation Development before becoming a Director of Engineering to support multiple commercial vaccine franchises. He earned a Ph.D. in chemical and biological engineering from Chalmers University of Technology, and an M.Eng. in biomedical engineering and a B.S. in chemical engineering from the Massachusetts Institute of Technology.

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Saryah Azmat

Saryah Azmat

Chief Business Officer

Ms. Azmat leads business development, corporate strategy, and capital formation at Turnstone. Her contributions and leadership have been critical to the growth of the business, including Turnstone’s recent acquisition of Myst Therapeutics and ongoing investor relations activities. Ms. Azmat joined Turnstone from Bristol-Myers Squibb (“BMS”), where she was the Global Lead for Oncology Search & Evaluation. During her six-year tenure at BMS, Ms. Azmat executed over 15 major transactions spanning all stages of preclinical and clinical development. Prior to BMS, she was a consultant for global biopharma clients at Putnam Associates, where she managed clinical and commercial stage projects. Ms. Azmat earned a B.A. in engineering sciences and a B.E. in biomedical engineering from the Thayer School of Engineering at Dartmouth College.

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Steve Bernstein, M.D.

Steve Bernstein, M.D.

SVP, Clinical Development and Translational Medicine

Steven Bernstein, M.D., has more than 20 years of experience as a treating physician, translational scientist and pharmaceutical executive.  Prior to joining Turnstone, Dr. Bernstein served as Chair, Immuno-Oncology Translational Research and Development, and Head, Integrated Science, at Bristol-Myers Squibb. Prior to BMS, he was as an academic physician scientist most recently at the University of Rochester’s James P. Wilmot Cancer Institute, where he was Professor of Medicine, Co-Director of the Hematological Malignancy and Lymphoma Biology Programs and Co-PI of the University of Rochester/Arizona Cancer Center NCI SPORE grant in lymphoma. Dr. Bernstein was a member of the Lymphoma Working Group of SWOG, and the Scientific Advisory Boards of both the Lymphoma Research Foundation and the Leukemia and Lymphoma Society.

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David Stojdl, Ph.D.

David Stojdl, Ph.D.

SVP, Discovery Research

Dr. David Stojdl pioneered the exploration of host-virus interactions critical to oncolytic therapy to guide the clinical development of more effective virus platforms. At the Ottawa Regional Cancer Centre, he first identified VSV as an oncolytic virus and defined the archetypal role of interferon signaling in tumor-specific oncolytic virus targeting. Since joining the CHEO Research Institute in 2004, Dr. Stojdl has discovered and developed several novel oncolytic vector platforms, including the Maraba oncolytic virus platform. Dr. Stojdl also directs the CHEO Automated Screening Centre (CASC), leveraging state-of-the-art high-throughput robotic screening technology to uncover new insights for the clinical development of oncolytic virus biotherapies. Dr. Stojdl is a professor in the Department of Pediatrics and Department of Biochemistry, Microbiology and Immunology at the University of Ottawa. He was a scientific co-founder and consultant to Jennerex Biotherapeutics (later acquired by SillaJen Biotherapeutics). He received a Ph.D. from the University of Ottawa and an M.S. and B.S. in microbiology and immunology from the University of Western Ontario.

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TJ Langer

TJ Langer

SVP, Cell Therapy Development and External Innovation
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Caroline Breitbach, Ph.D.

Caroline Breitbach, Ph.D.

VP, R&D Programs and Strategy

Dr. Caroline Breitbach joined Turnstone Biologics from SillaJen Biotherapeutics (formerly Jennerex) where she was Vice President, Clinical and Translational Research. In that position, she oversaw translational and early-stage clinical development of an oncolytic immunotherapy and contributed to lead candidate development from Phase 1 through initiation of Phase 3 evaluation. Previously, she worked in Dr. John Bell’s group at the University of Ottawa, where she evaluated acute effects of oncolytic viruses on the tumor immune microenvironment. She earned a Ph.D. in biochemistry from the University of Ottawa and an Honor’s B.Sc. in microbiology and immunology from McGill University.

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Maura Campbell, Ph.D.

Maura Campbell, Ph.D.

VP, Intellectual Property & Contracts

Dr. Maura Campbell has spent more than 20 years in technology transfer and the management and commercialization of intellectual property (IP). She has business management experience in all key sectors of biotech, including private and public companies, universities and research institutes, and government-funded public sector research organizations (National Centre of Excellence [NCE]). Maura joined Turnstone Biologics from VBI Vaccines where she served as Director, Intellectual Property. She also was with the Ottawa Hospital Research Institute (OHRI) as a Senior Research Program Manager, where she oversaw the oncolytic vaccine project commercialization. Earlier in her career, Maura was the Director of Intellectual Property for PainCeptor Pharma Corporation, the Manager of Technology Transfer & Commercialization for the OHRI, and the Manager of Technology Transfer at the Institute for Robotics and Intelligent Systems at NCE. She has served as an IP consultant to a number of Canadian start-ups including Neurochem, Conjuchem, Aonix, AMRIC and Sussex Research Labs. Maura received a Ph.D. in biochemistry from the University of Ottawa, and an M.Sc. and a B.Sc. in biochemistry from Queen’s University in Kingston.

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Karen Major

Karen Major

VP, Regulatory

Karen Major has 18 years of Regulatory Affairs experience, specializing in the global development of biotechnological oncology products.  Prior to joining Turnstone, she was Sr. Director Regulatory Affairs at Arbutus Biopharma, focusing on chronic HBV. Prior to that, she held the same position at Tekmira Pharmaceuticals, developing siRNA-LNP products in oncology, infectious disease and metabolic indications. Karen led the Regulatory Affairs departments at YM BioSciences (acquired by Gilead in 2013) and Viventia Biotechnologies. Karen holds an honors BSc in Pharmacology and Toxicology from the University of Toronto, a post-graduate diploma in Regulatory Affairs and Quality Operations from Seneca College, and a Regulatory Affairs Certification (RAC) from RAPS.

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Adina Pelusio

Adina Pelusio

VP, Clinical Operations

Adina Pelusio has more than 15 years of experience in drug development, most recently as the Vice President, Clinical Operations at SillaJen Biotherapeutics (formerly Jennerex, Inc), where she spent a decade advancing oncolytic viruses in clinical trials. In addition to overseeing the Clinical Operations department at SillaJen, she managed and pioneered the medical educator role to expand hospital personnel comfort and knowledge globally with oncolytic viruses. Prior to Jennerex, Ms. Pelusio served as a SWAT Senior Clinical Research Associate at PPD, a large, global CRO, where she was tasked with study rescue and served on a technology committee assigned with developing training for CRAs and project teams on new technologies within the field.

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Christine Blodgett

Christine Blodgett

Head of Human Resources
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Jerel Davis, Ph.D.

Jerel Davis, Ph.D.

Chairman & Director,
Versant Ventures

Dr. Jerel Davis is a Managing Director at Versant Ventures and is based in Vancouver. Since joining Versant in 2011, he has played a critical role in launching and investing in a number of Versant’s portfolio companies including Quanticel Pharmaceuticals, Crispr Therapeutics, Blueline Bioscience, Northern Biologics and several of the Inception Sciences discovery start-ups. He has also led Versant’s execution of build-to-buy structured acquisitions with Celgene, Roche and Bayer. Over the last few years, Jerel has focused on establishing Versant’s presence in Canada, including the launch of new companies in Vancouver, Toronto and Montreal. Prior to joining Versant, Jerel was Associate Principal at McKinsey and Company where he advised pharmaceutical, biotechnology, medical device and molecular diagnostics companies. He has worked in a number of healthcare markets globally including the United States, Europe, China, Russia and India. Jerel was a post-doctoral researcher at Stanford University and worked in research at Amgen.

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Brad Bolzon, Ph.D.

Brad Bolzon, Ph.D.

Director,
Versant Ventures

Brad Bolzon, Ph.D., is a Managing Director and Chairman of Versant. He combines 13 years of global pharmaceutical industry experience and a similar tenure as a venture capitalist. Brad is the architect of Versant’s investment strategy. His track record consists of successive outlier returns including Amira (sale), Okairos (sale), Speedel (sale), Quanticel (sale), Novira (sale), Flexion (2014 IPO), Crispr (2016 IPO), BioTie (sale), Jecure (sale), Inception (multiple sales) and BlueRock (sale), and he continues to manage several other promising investments.

Prior to joining Versant, Brad served as Executive Vice President, Global Head of Business Development, Licensing & Alliances at Roche. Under his leadership, Roche established alliances with over 75 venture-backed biotech companies worldwide and transformed its R&D pipeline into an industry leader. Prior to that, Brad held executive roles at Eli Lilly in drug discovery, clinical research, regulatory affairs and business development. He earned Master of Science and Ph.D. degrees in Pharmacology from the University of Toronto.

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Mike Burgess, M.B.Ch.B., Ph.D.

Mike Burgess, M.B.Ch.B., Ph.D.

Executive Director,
Turnstone Biologics, SpringWorks Therapeutics

Dr. Mike Burgess brings 20 years of drug research and development experience to Turnstone Biologics. At Bristol-Myers Squibb, he led strategy and execution of translational medicine, early-stage clinical trials and clinical pharmacology across all therapeutic areas, including oncology. Prior to this at Roche, Mike held several different senior leadership positions, including acting global head of Roche Pharma Research and Early Development (pRED) and Senior Vice President and Global Head of Oncology Research and Early Development. Before joining Roche, Mike spent 7 years at Lilly working on early stage oncology trials. Mike received his medical degree (MBChB) and a Ph.D. in molecular biology from the University of Bristol, UK and spent 10 years as a practicing physician in pediatrics and pediatric oncology.

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Sammy Farah, Ph.D., M.B.A.

Sammy Farah, Ph.D., M.B.A.

Director,
Turnstone Biologics

Dr. Sammy Farah has extensive vaccine expertise and almost 20 years of scientific, business and executive management experience in the biotechnology industry. He joined Turnstone Biologics from Synthetic Genomics Vaccines, Inc., where he served as President. Prior to that, he was Chief Business Officer of Immune Design Corp. And before then, Sammy was at Versant Ventures where he specialized in biotechnology investing and new company formation, and at Merck & Co., Inc. where he led technology support for multiple commercial vaccine franchises before joining the business development and licensing group to evaluate and execute new external technology and research partnerships. Dr. Farah earned an M.B.A. from the Wharton School at the University of Pennsylvania, a Ph.D. in biochemical engineering from Stanford University, and a B.S. in biochemical engineering from the Massachusetts Institute of Technology.

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Robert Gould

Robert Gould

Director,
Fulcrum Therapeutics

Robert Gould joined Fulcrum as president and CEO at the time of the company’s launch in 2016, bringing over 30 years of experience to the role. Previously, he served as president and CEO of Epizyme from 2010 to 2015. Prior to joining Epizyme, Robert served as director of novel therapeutics at the Broad Institute of MIT and Harvard from 2006 to 2010. Robert spent 23 years at Merck where he held a variety of leadership positions, culminating in the role of vice president, licensing and external research. Throughout his time at Merck, Robert was instrumental in advancing more than 20 compounds from discovery into clinical development in multiple therapeutic areas. Robert received a B.A. from Spring Arbor College and a Ph.D. from the University of Iowa and completed postdoctoral studies at the Johns Hopkins University.

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Rishi Gupta, J.D.

Rishi Gupta, J.D.

Director,
OrbiMed

Rishi Gupta is a private equity partner at OrbiMed. Prior to that, he was a healthcare investment banker at Raymond James & Associates, served as manager of corporate development at Veritas Medicine and was a summer associate at Wachtell, Lipton, Rosen & Katz. Rishi has published scientific articles on the mechanisms of HIV entry into host cells and legal articles on intellectual property laws in the developing world. In addition to Turnstone Biologics, he serves or has served on the boards of Dimension Therapeutics, Symbiomix Therapeutics, Avitide, Verona Pharma, ChemoCentryx and Sientra. He has also been actively involved with OrbiMed’s investments in Acceleron Pharma, CoGenesys, Supernus Pharmaceuticals, Adimab, Receptos, Aragon Pharmaceuticals, Seragon Pharmaceuticals, Alector, Arsanis, Biotie, Invitae and ORIC Pharmaceuticals. Rishi earned a J.D. from the Yale Law School and an A.B. degree magna cum laude in biochemical sciences from Harvard College.

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Stefan Larson, Ph.D.

Stefan Larson, Ph.D.

Director,
Sectoral Asset Management

Dr. Larson joined Sectoral in 2018 as Partner – Private Equity, responsible for leading biotechnology private equity investments. Prior to joining Sectoral, Dr. Larson was an Entrepreneur-in-Residence and later Venture Partner with Versant Ventures, where he led the establishment of their Toronto-based Discovery Engine and was the founding CEO of Northern Biologics. Dr. Larson was also a co-founder of two medical device companies: Perimeter Medical Imaging, and Tornado Spectral Systems. He began his career at McKinsey & Company in San Francisco and Toronto. Dr. Larson received his B.Sc. in Biology from McGill University, and his M.Sc. in Molecular and Medical Genetics from the University of Toronto, prior to completing his Ph.D. in Biophysics at Stanford University.

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Patrick Machado

Patrick Machado

Director,
Former CFO/CBO Medivation

Patrick Machado is a co-founder of Medivation, Inc., a biopharmaceutical company, and has served on its Board of Directors since April 2014. Prior to his retirement in April 2014, Mr. Machado served as Medivation’s Chief Financial Officer since its inception in September 2003 and as its Chief Business Officer since December 2009. From 1998 until 2001, Mr. Machado was employed by ProDuct Health, Inc., a privately-held medical device company, as Vice President, Chief Financial Officer and General Counsel from 1998 to 2000, and as Senior Vice President and Chief Financial Officer from 2000 to 2001. From 2001 until 2002, Mr. Machado served as a consultant to Cytyc Corporation, to assist with transitional matters related to Cytyc Corporation’s acquisition of ProDuct Health, Inc. Mr. Machado received a J.D. from Harvard Law School and a B.A. and B.S. in German and Economics, respectively, from Santa Clara University.

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Jeff Courtney

Jeff Courtney

In Memoriam

Jeff Courtney helped to form Turnstone Biologics and was an outstanding leader for FACIT (Fight Against Cancer Innovation Trust). Jeff’s life’s work and warm personality inspires all of us at Turnstone Biologics to drive forward our mission to help cancer patients, and we greatly miss his presence, leadership and friendship.

Partners

We are backed by top-tier investors and are partnered with multinational biopharmaceutical companies who are committed to Turnstone’s growth and developing transformative technologies that advance the treatment of cancer. Since our inception in 2015, we have raised $92 million in venture capital financing and executed two large biopharma partnerships with upfronts totaling over $200 million and with deal values in excess of $1 billion each.

In December 2019, Turnstone Biologics announced a global collaboration and license agreement with Takeda to develop novel viral immunotherapies from Turnstone’s proprietary vaccinia virus platform for a broad range of cancer indications.

In November 2017, Turnstone Biologics entered into a strategic research, option and license agreement with AbbVie to develop candidates from our maraba virus platform.

Careers

We continue to build a world-class team of specialists as we collaborate to transform cancer care. If you’re a passionate person, and our mission and science excite you, Turnstone Biologics might be for you.

Turnstone Biologics’ team works with a sense of urgency to fulfill our mission. Our decision-making is driven by science and our therapeutics are designed with the patient in mind. We value transparency, innovation, integrity and purpose. Our employees, with their relentless drive and expertise, are the basis of our success.

 

Team Opportunities

Turnstone Biologics is dedicated to excellence and innovation in every aspect of our science and business. We are actively looking for exceptional individuals who share our passion for developing and delivering next-generation cancer immunotherapies. We offer competitive compensation and benefits and are an equal opportunity employer.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

Our Senior Medical Director sits in the Clinical Development and Operations Groups that drives clinical development strategy, and the design, conduct, and interpretation of clinical trials.

The Senior Medical Director will have direct responsibility for the design, execution, oversight and analyses of clinical trials of Oncolytic Viral Therapy and Tumor Infiltrating Lymphocyte (TIL) therapy. This will include driving the clinical strategy, incorporating appropriate biomarker studies into the protocol and correlating clinical and translational findings to drive optimal clinical development in addition to providing medical and scientific expertise to cross-functional Turnstone colleagues.

Position Responsibilities:

· Medical Monitoring

· Medical review of trial data, including reviewing eligibility data

· Clinical site interactions including addressing medical questions and providing site education (including safety management guidelines)

· Assessment of key safety-related serious adverse events and approving safety narratives

· Drafting of clinical protocols, along with colleagues from Clinical Operations and providing the medical strategic oversight of the protocol including study design, targeted patient populations, inclusion and exclusion criteria and other safety-related clinical considerations

· Fulfilling GCP and compliance obligations for clinical conduct and maintaining all required training

· Contributing to the Clinical Strategy and Clinical Development Plans for the company’s assets

· Providing oversight and medical accountability for the company’s clinical trials

· Identifying and building relationships with principal investigators and thought leaders on the treatment modality, diseases of interest and in novel clinical designs and biomedical statistical analyses

· Supporting the executional delivery of clinical studies (e.g., site activation, status of enrollment, adjudication for protocol violations, significant, non-significant deviations and as the medical resource for the site investigators)

· Interacting with Health Authorities as the Clinical Trial Lead

· Drafting and Authoring clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with colleagues in Clinical Operations.

· Staying current on the clinical development and regulatory issues related to other competitive or relevant compounds in development and providing recommendations on changes needed to our strategy or clinical development plan as a result

· Maintaining a clinical and scientific reputation in the modalities and diseases pertinent to Turnstone

Requirements:

· MD required (or x-US equivalent)

· 4 or more years of Industry experience in oncology clinical trial development and execution

· Sub-speciality training in Medical Oncology and/or Hematology

· Ability to communicate and present information clearly in scientific and clinical settings

· Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation

· Knowledge and experience in the drug development process and in executing effective clinical plans and protocols

· Experience with oncolytic viruses and/or cellular therapy (or bone marrow transplantation) is preferred

· Strong leadership skills with proven ability to lead and work effectively in a team environment and cross-functionally

· Ability to travel both domestically and internationally

To Apply:

Please click here to apply!

Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

The Director of Program Management will design appropriate program management plans and processes to support clear communication, decision making, prioritization and resource planning. Interact collaboratively with colleagues to ensure alignment on project action items, deliverables, and vision. Responsible for planning and execution of product development projects in TIL portfolio. Plans and directs schedules and monitors budget/spending. Ensures consistent practices throughout all phases of the project life cycle. Drives the development and manages the execution of high quality, integrated cross-functional plans for projects. Applies project management best practices in the development, initiation, planning, execution, control and closing of projects. Provides clear direction on product development requirements to meet expectations of internal and external stakeholders. Interacts with research and development, manufacturing, clinical and regulatory departments and with external stakeholders. Responsible for project performance, risk management, administration, financial management and issue resolution for functional group.

• Ensuring that programs in the Research and Development portfolios are supported with appropriate and consistent Project/Program Management support, including:
o Facilitating the development of cross functional strategy and ensuring appropriate communication to internal stakeholders
o Defining program level plans that include scope, timelines, milestones, deliverables, key Go/NoGo decisions points, resources, and budgets
o Tracking and owning program timeline, milestone, and budget data
o Leading the team through planning for cross functional transitions
o Ensuring that changes to program timelines are appropriately communicated to the team and Leadership
o Coordinating team meetings as needed to meet team deliverables, track decisions and follow up on action items
o Working with the team to identify program risks and develop mitigation strategies
o Partnering with Program Team Leader to drive the team to clear and effective decision points.
• Ensuring that corporate alliances and/or academic collaborations are supported with Alliance management support, including:
o Facilitating joint team meetings at appropriate frequency to meet the needs of the team
o Ensuring internal team and leadership team is aware of and working towards meeting collaboration expectations
o Understanding Turnstone positions on strategic goals and ensuring appropriate communication to partner
o Ensuring team is meeting contractual obligations and flagging to leadership when contractual interpretation is required
• Maintaining close cross-departmental relationships to ensure that all critical parties are aware of project activities, issues and contingencies.
• Developing and implementing communication tools that enhance information exchange within program teams and across functions
• Serving as an integral member of the program management function, ensuring cross-functional alignment of program strategies.
• Driving high performing, cross-functional teams to promote effective communication and ensure integration and alignment of internal subject matter experts via team meetings and program updates
• Providing input along with other senior managers in establishment of strategic plans and objectives. Accountable for making final decisions on administrative or operational matters and ensuring operations effective achievement of objectives.
• Partnering with functional leaders to define project strategies and proactively identify and escalate risks, gaps and challenges, key dependencies and decisions points. Works with teams to develop scenarios and solve problems
• Tailoring program, approach and systems to small and rapidly growing organization

What’s in it for you?

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities for you to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!

We are in the early stages of building strategies, structures and process so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

Requirements:
• MSc or BSc Degree
• 12+ years experience in a project management role in a biotechnology or pharmaceutical company
• PMP Project Management Certificate preferred
• Experience with cell therapy programs preferred
• Familiar with drug development process and a demonstrated understanding of the clinical development process
• Ability to foster business relationships with internal and external business partners.
• Proven ability to influence others to get things done without formal authority.
• Demonstrated ability to map out new business processes and improve existing processes
• Ability to facilitate, negotiate and communicate in cross-functional team environment to achieve overall project goals.
• Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Effective communication, interpersonal skills, collaboration and negotiation skills
• Highly organized and efficient, close attention to details and able to orchestrate multiple projects simultaneously
• Able to represent and communicate project timelines/priorities at senior management meetings
• Proficiency in using Microsoft Office suite – Word, Excel, PowerPoint and Project.

To Apply:
Please click here to apply!

Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

The Research Associate or Senior Associate, in this individual contributor, lab-based role, will work in a collaborative environment to perform Analytical testing and development to support Turnstone’s TIL cell therapy development programs. This position will join the development group and work with the analytical testing group that values data quality, high productivity and teamwork. The key deliverables for this role are precise, accurate, and high-quality data presented, communicated, and integrated in an effective manner. This position will require thorough documentation of all experimental steps and final data readout.

Responsibilities:

• Execution of key analytical methods such as multi-parameter flow cytometry, bioassays and qPCR-based methods and data analysis in support of process development activities, product characterization, and raw materials testing.
• Provide support to other groups for assay development, qualification, and transfer into Analytical Development
• Developing processes and methods to improve lab execution and data analysis
• Timely and thorough documentation and completion of electronic laboratory notebooks
• Author reports detailing experimental work and summarizing results
• Contribute to an overall high-performing laboratory, with a willingness to contribute in all ways, such as ordering, tracking, and maintaining inventory of lab supplies and reagents

Experience & Qualifications:

    • BS in a scientific discipline 2+ yrs experience (1+yrs with MS) of relevant industrial experience. Final role can be commensurate with relevant industry experience.
    • Experience with flow cytometry or cell-based bioassays, ELISA, and PCR techniques
    • Experience with aseptic cell culture and cell-based assays.
    • Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench.
    • Experience with other techniques in molecular biology, such as RT-PCR is preferred
    • Previous experience with cell therapy products is preferred
    • Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects
    • Experience working in a self-driven, performance/results oriented, fast paced matrix environment
    • Working knowledge of statistical software (R, JMP, Minitab) is preferred.

    To Apply:
    Please click here to apply!

    Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

As an Engineer or Sr. Engineer (depending on your relevant experiences and expertise), you will provide process development and engineering support for process design, characterization, and improvements with a goal of ultimately enabling GMP manufacturing. Primary responsibility will be to design, lead, and execute experiments that contribute to development and characterization of the TIL cell therapy manufacturing process. Experiments will be performed to identify and define Critical Process Parameters and process ranges. Additionally, you will draft and review study plans and reports, analyze and trend process data, perform Design of Experiments (DoEs), and provide technical support for manufacturing sciences, technology, and process changes. Turnstone works in a highly cross-functional environment, so your contributions will be critical for our pre-clinical, clinical, and regulatory workflows, with an opportunity to engage and enable your colleagues across the business.

Responsibilities:

• Develop manufacturing processes for cell therapy products and develop process improvements and efficiencies
• Lead and execute laboratory studies to support process design and development, characterization and process improvements
• Write and review technical documentation
• Participate and report to a cross-functional development team to advance production activities
• Assist in technology transfer to GMP manufacturing by generating development reports and providing on-site technical support.
• Authoring and assistance in the technical review of supporting documents, reports, including CMC sections for regulatory filings.
• This is a hands-on position requiring conducting laboratory experiments, good documentation review skills, good writing skills, and the flexibility to move between the management and execution of each required function as needed.
• Act as technical expert to train and supervise process technicians

Experience & Qualifications:

    • Minimum of 3 years of relevant industry experience, with role flexibility available commensurate with experience
    • Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical/biotech manufacturing & process development experience required
    • Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
    • Cell culture and aseptic processing experience
    • Working knowledge of scientific and engineering principles
    • Experience in statistical analysis using JMP or Minitab
    • Practical experience in GMP operations
    • Ability to function efficiently and independently in a changing environment
    • Self-motivated and willing to accept temporary responsibilities outside of initial job description
    • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
    • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
    • The primary location of the position is San Diego, but may be required to travel, based on business priorities

    To Apply:
    Please click here to apply!

    Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

As the Head of Viral Bioprocess and Analytical Development (Senior Director or VP, commensurate with relevant industry experience) , you will be an important member of the Technical Operations leadership team reporting to the Chief Technology Officer. You will be responsible for providing overall direction of our analytical and process development strategy across Drug Substance and Drug Product for a portfolio of live virus therapeutics based in our RIVAL platform (highly engineered vaccinia virus). Among your responsibilities will be:

• Participate as an active member of the Technical Operations leadership team and contribute to overall company strategy for CMC and Technical Operations
• Provide leadership and guidance to a team of Scientists and Engineers, with the intent of being a leader of leaders
• Set the analytical development strategy for methods spanning process and product characterization, and collaborating closely with the analytical life-cycle and QC team for technology transfer of new release and characterization methods
• Lead the process development strategy for early phase clinical development, through pivotal and commercial drug substance (DS) manufacturing
• Support scale up and technical transfer of novel processes to GMP manufacturing partners
• Set the drug product (DP) image and work with Supply Chain to develop strategy for robust shelf life of all virus products
• Lead all aspects of clinical handling and administration to develop improved viral delivery systems (IV infusion, IT or IM injections) to enable optimization of pharmacy DP handling and administration
• Participate in a cross-functional matrix team (Clinical, Manufacturing, Supply Chain, Regulatory, Quality, Tech Ops) to develop overall DS development strategy for a suite of viral-based products (RIVAL pipeline)
• Provide a depth of technical leadership for DS process development spanning cell line and media development, cell strain optimization, bioreactor design, selection and control strategies, harvest, lysis, clarification, chromatography and separation/filtration technologies
• Represent Turnstone CMC externally at our expansive international CDMO network
• Participate in regulatory strategy and document authoring/reviewing for interactions with FDA, EMA, Health Canada, MFDS, and other jurisdiction as they emerge
• Drive corporate and departmental objectives to completion through strong collaboration with a broad range of internal functions, in particular Regulatory Affairs and Quality Assurance

What’s in it for you?

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size (approximately 100 team members, and growing fast!) we will give you plenty of opportunities to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!

We are in the early stages of building strategies, structures and process so this role will be busy and expanding. We also have opportunities for you to be a mentor to other team members. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

Experience & Qualifications:

    Turnstone Technical Operations is a virtual organization, where the majority of our wetbench work is executed at third party CDMO/CRO partners. We have offices in Ottawa, Canada and San Diego, USA and this role would ideally inspire you to relocate. Most of our virus development team is stationed in Ottawa and most of our partnerships are in Europe – therefore being in Ottawa would be ideal, but if you believe you can be successful in San Diego, we would love to speak with you! This role is best suited for someone with the following:

    • 10+ years of overall experience within the biotech/pharmaceutical industry
    • Minimum of 5+ years of leadership experience demonstrated as either having direct reports, and/or demonstrated leadership across complex projects and cross functional teams
    • Scientist or Engineer with advanced degree (PhD strongly preferred but not required)
    • Experience with process scale up, deployment and technology transfer of complex biological processes in a GMP manufacturing environment, and process qualification/validation are strongly preferred
    • Strong interpersonal skills required
    • Proven expertise and technical depth in upstream process development (mammalian cell culture expression systems, ideally for the manufacture of live-viruses), and/or downstream process development is required
    • Educated in one of the following fields: Biochemical Engineering, Biological/Biomedical Engineering, Virology, Biology, or Biochemistry
    • Broad exposure to different biological drug products. Experience working with viruses considered a very strong asset.
    • Self-motivated and efficient, able to manage responsibilities with an appropriate sense of urgency, and function effectively in a fast-paced and dynamic environment
    • The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility
    • Able to manage competing priorities effectively and adapt to changing priorities
    • Analytical and quantitative approach to problem solving, with the ability to self-start and independently investigate technically challenging problems

    To Apply:
    Please click here to apply!

    Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities for you to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!

We are in the early stages of building strategies, structures and process so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

Our Virus Manufacturing (VMFG) team is growing. As part of the Technical Operations organization, the VMFG team is responsible for the GMP manufacture of Cell Banks, Virus Banks, Drug Substance and Drug Product for our clinical-stage assets. VMFG supports technology transfers and collaborates closely with the Virus Development & Manufacturing Sciences team to develop and capture process knowledge and ensure overall manufacturing success. As an Associate Engineer of Virus Manufacturing on the VMFG team, you will be tasked with supporting manufacturing campaigns from end-to-end within our external contract manufacturing organization (CMO) network.

The responsibilities for this position span across our multi-modal platform and include:

– Support virus manufacturing campaigns with external CMO partners
– Support virus manufacturing batch readiness including process definition, raw material procurement, and batch documentation preparation
– Support ongoing batch monitoring including person-in-plant coverage
– Support cross functional teams troubleshooting and resolving issues with ongoing manufacturing runs
– Support virus manufacturing campaign closeout including the review of executed batch records and shipping/logistics of finished material
– Support process development, engineering runs, and other process scale-up related studies
– Support the identification and selection of new external CMO partners
– Support drafting of regulatory documentation including INDs, CTAs, etc.
– Represent the Virus MFG team at Technical Operations cross-functional program meetings

Experience & Qualifications:

    • This Associate Engineer role will be formally positioned out of our Ottawa, Canada office
    • Willingness to travel (when it’s safe as it pertains to global pandemic) up to 10-30% to other Turnstone sites and/or external CMOs throughout North America (USA, Canada) and Europe
    • BSc in a science, engineering, or biotechnology related discipline; MSc considered an asset
    • 1-3 years’ experience in a technical operations or research/development role
    • Experience with live virus based therapeutic manufacturing such as viral immunotherapies, vaccines, cell and gene therapies, or other complex biologics
    • Experience with good manufacturing practices (GMP) in a clinical or commercial manufacturing setting
    • Experience with the qualification and operational use of single use, small scale mammalian cell culture, tangential flow filtration, and/or chromatography-based purification equipment and raw materials
    • Comfortable in a dynamic environment with competing priorities
    • Strong technical writing skills
    • Teamwork – willingness to lead and willingness to be lead when it’s appropriate
    • Positive Attitude – interest in learning how to adapt to fast-growing teams and a dynamic virtual working environment
    • Communication – interest in learning how to communicate effectively cross functionally with multiple levels in the organization and externally to global partners
    • Growth mindset – constant approach of challenging oneself to learn more, learn faster, and learn better
    • Excellent computer skills, including Microsoft Excel and PowerPoint

    To Apply:
    Please click here to apply!

    Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

The Manager (or Sr Manager), Supply Planning will be responsible for investigational product (IP) supply for a clinical development program which is rapidly maturing and expanding to multiple global jurisdictions. The intent of the role is to start with a focus on our active early phase viral immunotherapy clinical studies, with potential opportunities to support other product modalities and product intermediates.

The responsibilities for this position include but are not limited to:

– Lead the integration of the clinical development plan and the manufacturing plan to create an actionable, end-to-end, long range strategic supply plan

– Lead the constant iterative re-modeling of supply plan scenarios to help inform program-level and functional-level decision-making across clinical development and technical operations

– Lead manufacturing campaigns at label-and-pack contract manufacturing organization (CMO) partners to create finished goods (FG/IP) ready for clinical distribution

– Partner with Regulatory Affairs and Clinical Operations to develop and manage IP and ancillary product labels for multiple jurisdictions

– Lead selection, strategic integration, and activation, and ongoing operation of clinical supply depots for IP, ancillary supplies, and other stored materials required for global clinical trials

– Monitor clinical IP supplies at sites and depots and provide supply metrics to support clinical operations needs around the globe

– Lead relationship management of label-and-pack CMO partners and the evaluation and selection of new CMO partners

– Lead GMP inventory management, including the tracking of actual inventory, as well as driving development of the tools, systems, and naming conventions utilized to enable efficiency and compliance

– Serve as a key stakeholder in the Technical Operations and Clinical Operations interface, including leading cross-functional meetings and teams to achieve integration of workstreams (production planning, testing planning, clinical operations, etc.)

Experience & Qualifications:

    This Manager (or Sr Manager) role will be formally positioned out of our San Diego, CA office but working from home/remotely will be a part of the normal work routine

    – Willingness to travel (during normal times) up to 10-20% to other Turnstones sites and/or external CMOs throughout North America (USA, Canada) and Europe

    – BS degree in a relevant life sciences, engineering, or business management discipline

    – 5-8 years’ experience in a clinical supply chain management across early to late phases of clinical development and multiple jurisdiction (Europe, Asia-Pacific, North America)

    – 3-5 years’ experience in a team and/or cross-functional leadership role

    – Strong understanding of and experience with GMP and GCP requirements

    – Experience with implementation and operations of ERP (Oracle, SAP or NetSuite) and Interactive Response Technology (IRT) systems

    – Experience working with and managing multiple third-party/external partners

    – Experience with global clinical trials, ultralow cold chain, and sourcing of comparator IMPs highly preferred

    – Excellent Excel abilities required

    – Teamwork – willingness to lead and willingness to be lead when it’s appropriate

    – Positive Attitude – ability to adapt to fast-growing teams and a dynamic virtual working environment

    – Communication – must be able to communicate effectively cross functionally with multiple levels in the organization and externally to global partners

    – Growth mindset – constant approach of challenging oneself to learn more, learn faster, and learn better

    To Apply:
    Please click here to apply!

    Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

As the Sr. Engineer/Sr. Scientist of upstream process development, you will report to the Head of Drug Substance Process Development. As part of this role, you will lead all of the technical aspects of our virus process development program across cell line, media/feed strategies, infection/harvest and bioreactor scale up and development. You will be a critical member of our Process Development team and help contribute to the overall strategy and execution of our virus CMC and translation. Specifically, you will:

• Develop the upstream process development targets and strategy to reach our program needs across a suite of virus-based drug products
• Contrinute as the subject matter expert to the overall upstream process development of our virus pipeline supporting cell line development, media development, feed strategy development, infection and harvest conditions, and bioreactor scale up
• Lead interactions with our external CDMO network to accomplish efficient process development advancement
• Collaborate with Drug Product development, Manfuacturing Sciences and Manufacturing Operations to support smooth translation of processes through inception to clinical manufacturing
• Participate in technology transfer of our processes to local and international GMP partners
• Support Manufacturing Sciences team with scale-up of the manufacturing processes, and deviation investigations
• Employ QbD principals to perform process characterization studies
• Act as subject matter expert for review of data in regulatory filings

What’s in it for you?:

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size (approximately 100 team members, and growing fast!) we will give you plenty of opportunities to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!

We are in the early stages of building strategies, structures and process so this role will be busy and expanding. We also have opportinites for you to be a mentor to other team members. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

Experience and Qualifications:

Turnstone Technical Operations is a virtual organization, where the majority of our wetbench work is executed at third party CMO/CRO partners. We have offices in Ottawa, Canada and San Diego, USA and this role would ideally inspire you to relocate. Most of our virus development team is stationed in Ottawa and most of our partnerships are in Europe – therefore being in Ottawa would be ideal, but if you believe you can be successful in San Diego, we would love to speak with you! This role is best suited for someone with the following:

• Scientist or Engineer with advanced degree in Biochemical Engineering, Biotechnology or in other related Science field (virology, biology, biochemistry, protein chemistry, pharmaceutical chemistry)
• 5-7 years of experience in upstream process development within biotech/pharma
• Experience with process scale up, deployment and technology transfer of complex biological processes in a GMP manufacturing environment, and process qualification/validation are strongly preferred
• Proven expertise and technical depth in upstream process development (mammalian cell culture expression systems, ideally for the manufacture of live-viruses) is required
• Experience with media and feed development strategies
• Expertise in microcarrier, and aseptic process experience, is strongly preferred
• Experience leading bioreactor development workstreams and support scale up from benchm, to pilot, to GMP scale SUB
• Excellent communication skills with the proven ability to build open and collaborative relationships, work effectively as a member of a multidisciplinary team
• Self-motivated and efficient, able to manage responsibilities with an appropriate sense of urgency, and function effectively in a fast-paced and dynamic environment
• The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility
• Able to manage competing priorities effectively and adapt to changing priorities
• Analytical and quantitative approach to problem solving, with the ability to self-start and independently investigate technically challenging problems
• Excellent computer skills, including JMP, Microsoft Excel, Powerpoint and Word

To Apply:
Please click here to apply!

Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding are what we call ‘another Wednesday at Turnstone’? At Turnstone, the science drives decision making, and our drugs are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you.

As the Head of Drug Substance Process Development, you will provide leadership to a team of Scientists and Engineers and drive the development strategy for early clinical development through commercialization for all upstream and downstream process development across our suite of viral-based drug products. Reporting to the head of viral development, you will:

· Participate as an active member of the Viral Development leadership team, to support overall analytical and process development needs across Drug Substance and Drug Product development

· Participate in a cross-functional matrix team (Clinical, Manufacturing, Supply Chain, Regulatory, Quality, Tech Ops) to develop overall Drug Substance development strategy for a suite of viral-based products (RIVAL pipeline)

· Provide leadership and guidance to a team of Scientists and Engineers

· Provide a depth of technical leadership for process development spanning cell line and media development, cell strain optimization, bioreactor design, selection and control strategies, harvest, lysis, clarification, chromatography and separation/filtration technologies

· Represent Turnstone CMC externally at our expansive international CDMO network

· Work closely with the Analytical Development team to ensure appropriate and robust assays are in place to support process characterization studies

· Participation in regulatory strategy and document authoring/reviewing for interactions with FDA, EMA, Health Canada, MFDS, and other jurisdictions as they emerge

· Drive corporate and departmental objectives to completion through strong collaboration with a broad range of internal functions, in particular Regulatory Affairs and Quality Assurance

Experience & Qualifications:

    In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size (approximately 100 team members, and growing fast!) we will give you plenty of opportunities to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!

    We are in the early stages of building strategies, structures and process so this role will be busy and expanding. We also have opportunities for you to be a mentor to other team members. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

    The Details

    Turnstone Technical Operations is a virtual organization, where the majority of our wetbench work is executed at third party CMO/CRO partners. We have offices in Ottawa, Canada and San Diego, USA and this role would ideally inspire you to relocate. Most of our virus development team is stationed in Ottawa and most of our partnerships are in Europe – therefore being in Ottawa would be ideal, but if you believe you can be successful in San Diego, we would love to speak with you! This role is best suited for someone with the following:

    · 8-10 years of overall experience within the biotech/pharmaceutical industry

    · Minimum of 3 years of leadership experience demonstrated as either having direct reports, and/or demonstrated leadership across complex projects and cross functional teams

    · Scientist or Engineer with advanced degree (PhD strongly preferred but not required)

    · Experience with process scale up, deployment and technology transfer of complex biological processes in a GMP manufacturing environment, and process qualification/validation are strongly preferred

    · Strong interpersonal skills required

    · Proven expertise and technical depth in upstream process development (mammalian cell culture expression systems, ideally for the manufacture of live-viruses), and/or downstream process development is required

    · Educated in one of the following fields: Biochemical Engineering, Biological/Biomedical Engineering, Virology, Biology, or Biochemistry

    · Broad exposure to different biological drug products. Experience working with viruses considered a very strong asset.

    · Self-motivated and efficient, able to manage responsibilities with an appropriate sense of urgency, and function effectively in a fast-paced and dynamic environment

    · The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility

    · Able to manage competing priorities effectively and adapt to changing priorities

    · Analytical and quantitative approach to problem solving, with the ability to self-start and independently investigate technically challenging problems

    To Apply:
    Please click here to apply!

    Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding are what we call ‘another Wednesday at Turnstone’? At Turnstone, the science drives decision making, and our drugs are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you.

As the Associate Director of Formulation and Drug Product Development, you will provide leadership to a team of Scientists, drive the strategic development plan and direct all Drug Product (DP) and formulation development efforts to support our viral-based platforms (RIVAL). Reporting to the head of viral development, you will:

· Participate as an active member of the Viral Development leadership team, to support overall analytical and process development needs across Drug Substance and Drug Product development

· Manage a cross-functional matrix team (Clinical, Supply Chain, Regulatory, Quality, Tech Ops) to develop overall Drug Product development strategy for a suite of viral-based products

· Provide leadership and guidance to a small team of Scientists

· Drive development of improved viral delivery systems (IV infusion, IT or IM injections) to enable optimization of pharmacy DP handling and administration

· Drive the overall stability program to inform target shelf-life parameters

· Work closely with the Analytical Development team to ensure appropriate and robust assays are in place to enable stability assessments, and drug product characterization

· Lead all aspects of pre-formulation and formulation development across a range of DP images (liquid, and lyophilization)

· Drive to definition of DP critical quality attributes through forced degradation studies and advanced analytical tools

· Support biophysical analytical development and design of characterization studies

· Participation in regulatory strategy and document authoring/reviewing for interactions with FDA, EMA, Health Canada, MFDS, and other jurisdiction as they emerge

Experience & Qualifications:

    Turnstone Technical Operations is a virtual organization, where nearly all of our wetbench work is executed at third party CMO/CRO partners. We have offices in Ottawa, Canada and San Diego, USA and ideally you feel motivated to relocate for this role to one of those sites. Most of our virus development team is stationed in Ottawa Canada, and most of our partnerships are in Europe – therefore relocating to Ottawa would be ideal, but if you feel you can be successful from San Diego, then let’s chat! This role is best suited for someone with the following:

    · 8-10 years of overall experience within the biotech/pharmaceutical industry

    · Minimum of 3 years of leadership experience demonstrated as either having direct reports, and/or demonstrated leadership across complex projects and cross functional teams

    · Scientist with advanced degree (PhD strongly preferred but not required)

    · Strong interpersonal skills required

    · Experience developing and/or interpreting biophysical analytical methods

    · Expertise developing novel formulations (experience developing live virus formulations considered a very strong asset)

    · Experience working with drug transfer devices and planning pharmacy handling procedures

    · Expertise managing stability programs considered a strong asset

    · Educated in one of the following fields: Biochemical Engineering, Biological/Biomedical Engineering, Virology, Biology, or Biochemistry

    · Experience designing, and planning accelerated studies to evaluate degradation pathways and define CQAs

    · Excellent computer skills, including Microsoft Excel and Powerpoint

    · Able to manage competing priorities effectively and adapt to changing priorities

    · Self-motivated and efficient, able to manage responsibilities with an appropriate sense of urgency, and function effectively in a fast-paced and dynamic environment

    · The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility

    To Apply:
    Please click here to apply!

    Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

If you are interested in being a part of a growing Regulatory Affairs and Quality Assurance team, then this role may be for you! As the Associate Director, Cell Therapy Quality Assurance, Reporting to the Head of Quality you will establish and implement the quality strategy which enables GXP compliance in accordance with country regulations and guidelines, as well as the company’s policies and procedures. The focus will be on GMP for the Turnstone cell therapy platform, with strong interfaces to the technical operations teams, clinical operations teams (GCP) and pre-clinical/R&D team (GLP), as well as a strong partnership to the Turnstone virus platform.

The responsibilities and critical expectations include the following:

1. Some QA professionals will provide regulatory guidelines, guidance documents, position papers, or other resources that are supplied by various regulatory bodies and/or trade organizations to help guide development. We are not looking for someone to provide those resources. We are looking for someone who deeply understands our science, our patients, our products, and our context, and provides interpretations, proposals, recommendations, and solutions of how we might apply those resources. We need hands-on problem solvers.
2. Some QA professionals will review development, manufacturing, and testing approaches, SOPs, batch records, and supply chain documentation and identify deviations, gaps, issues, and challenges that need to be addressed, and then pass those on. We are looking for a QA professional where supply of product – compliant, right-first-time, all the time, every time – is part of their core responsibilities. QA is as responsible for supply as manufacturing operations, manufacturing sciences, project management, QC regulatory affairs, and everyone else in the team. We own it, together.

If you share the above core philosophy, then below are some of the activities you will channel those core beliefs into:

• Develop, establish and maintain QA programs, policies, and procedures to ensure GxP compliance of clinical trial material.
• Manage the oversight of contract manufacturers and research organizations to ensure products/deliverables meet all required quality standards and specifications.
• Perform rapid and agile record review and disposition activities for clinical trial material including manufacturing, testing and labelling/packaging batch records
• Lead extensive investigations with vendors and interdepartmental teams to determine product quality impact and resolve potential product quality issues.
• Oversee the generation, review and/or disposition of internal and external documents used in GxP activities.
• Act as the single point of QA contact with vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues
• Drive the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GxPs.
• Interpret regulatory agency policies and guidance as it pertains to QA issues.
• Review CMC documents submitted to regulatory agencies.
• Develop work instructions and/or standard operating procedures

What’s in it for you?

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth we will give you plenty of opportunities for you to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!

We are in the early stages of building strategies, structures and process so this role will be busy and expanding. We also have opportinites for you to be a mentor to other team members. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

Experience & Qualifications:

    This role is best suited for someone with the following:

    • BA/BS Degree, with an advanced degree preferred
    • Minimum of 8+ years of operational quality assurance and GxP compliance. Requires manufacturing experience in a pharma or biotech environment, ideally across a full range of multiple clinical development phases
    • Prior experience with quality systems and advancing novel autologous therapeutics from preclinical stages through IND to BLA (or EU equivalents) is desired. Understanding of the biologics and cell therapy manufacturing process in GXP environments.
    • Experience with regulatory authority or client/partner inspections/audits, and conduct of supplier/manufacturer audits.
    • Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
    • Strong knowledge of current industry trends and the ability to use the latest technologies
    • Experience with computer system validation (CSV) and knowledge of CFR Part 11 compliance would be an asset.
    • Demonstrated ability to manage multiple projects and variable workloads with demanding timelines.
    • Strong interpersonal, teamwork, and organizational skills; effective oral and written communication skills.
    • The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility

    To Apply:
    Please click here to apply!

    Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:

Our Senior Medical Director sits in the Clinical Development and Operations Groups that drives clinical development strategy, and the design, conduct, and interpretation of clinical trials.

The Senior Medical Director will have direct responsibility for the design, execution, oversight and analyses of clinical trials of Oncolytic Viral Therapy and Tumor Infiltrating Lymphocyte (TIL) therapy. This will include driving the clinical strategy, incorporating appropriate biomarker studies into the protocol and correlating clinical and translational findings to drive optimal clinical development in addition to providing medical and scientific expertise to cross-functional Turnstone colleagues.

Position Responsibilities:

· Medical Monitoring

· Medical review of trial data, including reviewing eligibility data

· Clinical site interactions including addressing medical questions and providing site education (including safety management guidelines)

· Assessment of key safety-related serious adverse events and approving safety narratives

· Drafting of clinical protocols, along with colleagues from Clinical Operations and providing the medical strategic oversight of the protocol including study design, targeted patient populations, inclusion and exclusion criteria and other safety-related clinical considerations

· Fulfilling GCP and compliance obligations for clinical conduct and maintaining all required training

· Contributing to the Clinical Strategy and Clinical Development Plans for the company’s assets

· Providing oversight and medical accountability for the company’s clinical trials

· Identifying and building relationships with principal investigators and thought leaders on the treatment modality, diseases of interest and in novel clinical designs and biomedical statistical analyses

· Supporting the executional delivery of clinical studies (e.g., site activation, status of enrollment, adjudication for protocol violations, significant, non-significant deviations and as the medical resource for the site investigators)

· Interacting with Health Authorities as the Clinical Trial Lead

· Drafting and Authoring clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with colleagues in Clinical Operations.

· Staying current on the clinical development and regulatory issues related to other competitive or relevant compounds in development and providing recommendations on changes needed to our strategy or clinical development plan as a result

· Maintaining a clinical and scientific reputation in the modalities and diseases pertinent to Turnstone

Requirements:

· MD required (or x-US equivalent)

· 4 or more years of Industry experience in oncology clinical trial development and execution

· Sub-speciality training in Medical Oncology and/or Hematology

· Ability to communicate and present information clearly in scientific and clinical settings

· Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation

· Knowledge and experience in the drug development process and in executing effective clinical plans and protocols

· Experience with oncolytic viruses and/or cellular therapy (or bone marrow transplantation) is preferred

· Strong leadership skills with proven ability to lead and work effectively in a team environment and cross-functionally

· Ability to travel both domestically and internationally

To Apply:

Please click here to apply!

Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Position Overview:
Reporting to the Vice President, Clinical Operations, the Clinical Project Manager (CPM) is responsible for the overall management and execution of operational activities involved in the planning, implementation, conduct and completion of clinical trials. This includes management of study deliverables, adherence to budget and timelines, negotiating vendor agreements, approving vendor and Investigator invoices and accruals, and ongoing risk mitigation. The CPM leads and engages with cross functional study teams and stakeholders (program management, site education and monitoring, clinical science, data management, biostatistics, medical writing, medical affairs, regulatory affairs, clinical accounting, and clinical QA) to ensure the project is completed on time, within budget, and with high quality.

Responsibilities:

· Manage and coordinate all aspects of assigned global clinical trials to ensure they are conducted in accordance with established protocols, Company standards (SOPs), ICH/GCP and applicable jurisdiction regulations.

· Identify and manage the identification, evaluation, and selection of external vendors (central lab, CROs, consultants/contractors, etc.) from RFP through budget/ contract negotiations and execution.

· Performs ongoing vendor management to ensure deliverables, high performance standards, and adherence to the contract or change order

· Oversees, manages and reports on project activities, including scope, schedule, budget and risk associated with each assigned project.

· Identifies and tracks key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)

· Develops clinical trial timelines and operational budget, tracks the overall study critical path and manages/oversees all study activities to ensure on-time study delivery.

· Reports study performance and timelines to senior management

· Assists in the identification, selection and initiation of clinical sites

· Oversees the development of required study plans and execution of those plans related to site monitoring, safety management, data management and biostatistics

· Oversees development of CRFs and clinical and safety databases

· Plans, coordinates and conducts investigator meetings globally

· Plans, coordinates and conducts Data Safety Monitoring Board (DSMB) meetings

· With Medical Affairs, assesses trends in data including adverse events, protocol violations, etc.

· Coordinates and manages timely database freeze and database lock.

· Participates in data review meeting.

· Ensures eTMF maintenance in accordance with regulatory standards and requirements

· Assists the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents

· Assists Regulatory Affairs as necessary for IND/CTA filing and other necessary compliance requirements.

· Ensures that clinical operations milestones are prioritized and that team members remain on task to achieve business and departmental goals

· Leads clinical operations meetings with vendors, interdepartmental staff, and alliances.

Experience & Qualifications:

    Qualifications:

    BS in scientific discipline or pharmacy, RN, or BSN degree or equivalent combination of education and experience
    Minimum 2 years of clinical trial/project management experience. Prior experience as a CRA or on-site is preferred, as well
    Oncology experience required
    Oncolytic virus, cell therapy, or immunotherapy experience is preferred.
    Ability to travel internationally or domestically up to 10-20% based on study demands
    Excellent working knowledge of GCP/ICH Guidelines
    Ability to work effectively independently or as part of a team, remotely or in-office
    Comfortable managing multiple projects and ability to adapt to changing priorities
    Effective written communication skills and computer skills are required
    Strong understanding of Clinical Development
    Self-starter and able to “wear many hats” while communicating with a cross-function team in a mid-sized biotech.

    To Apply:
    Please click here to apply!

    Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Contact

New York City

920 Broadway, 16th Floor,
New York, NY 10010, US
(347) 897-5988

Ottawa

12 York Street, 3rd Floor,
Ottawa, ON K1N 5S6, CA
(613) 421-8930

Business Development and Partnering

bd@turnstonebio.com