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.
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.
· 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
· 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
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.