Turnstone Biologics is a clinical stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach with a clinically validated technology, tumor infiltrating lymphocyte (TIL) therapy. Turnstone’s innovative TIL therapy, which is designed to extend the efficacy of TILs to multiple solid tumor indications by selecting and manufacturing the most potent tumor-reactive T-cells (Selected TILs) for tumor eradication, represents the Company’s foundational therapeutic modality driving its cancer immunotherapy pipeline. The Company recently commenced two clinical trials in various solid tumor types with its lead Selected TIL therapy candidate, TIDAL-01, one of which is in collaboration with Moffitt Cancer Center. Turnstone is developing additional strategies to further potentiate the clinical benefit of Selected TILs, including use in combination with their novel viral immunotherapy.
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.
Job Summary
Reporting to the Vice President, Clinical Development, the Director, Clinical Science will be a key contributor to Turnstone’s clinical development programs. The Director is supporting the planning and execution of clinical studies in a timely manner, in adherence with GCP, appropriate SOP’s and government regulations. He / She also conducts ongoing medical/safety data reviews, plans and supports study reporting and acts as a primary point-of-contact for site specific clinical questions.
Responsibilities
- Under the direction and oversight of the VP, Clinical Development, design, oversee and/or execute, as needed and as appropriate, key clinical deliverables including document development necessary for study design, activation, conduct and reporting (protocols, ICFs, IBs, CRFs, SAPs, Clinical study reports (CSRs).
- Assume a lead role in clinical study data review and interpretation and contribute to the development of deliverables required for ongoing study data review process.
- Work closely with individuals in other functional areas (e.g., clinical operations, project and program management, safety and pharmacovigilance, regulatory affairs and quality, pre-clinical and research, manufacturing, finance, contract resources, vendors etc.) in the creation, management, and execution of the clinical development plans, in developing innovative and efficient solutions to medical and scientific clinical trial issues, and ensuring the successful execution and completion of Turnstone’s clinical trials.
- Contribute content to regulatory submissions (INDs, NDAs, MAA etc.) as well as to documents to support Regulatory Authority interactions (briefing books, response documents etc.).
- Provide medical and scientific input and generate content for abstracts, posters, presentations and manuscripts.
- Contribute medical and scientific input into the Clinical Development Plans for preclinical and early-stage clinical assets.
- Identify risks, develop risk mitigation plans, and escalate risk mitigation strategies as appropriate.
- Contribute to and optimize an effective KOL and investigator communication strategy, interacting with investigators as warranted to obtain necessary information before, during and after the study.
- Working with other departments, create functional policies and procedures to provide strong and efficient clinical development processes that are appropriate for a matrixed environment.
- Ensure that relevant SOPs are current and complete.
- Assess, recommend, track functional budgetary and staffing needs for medical/clinical aspects of clinical trials.
- May also assist with other broad or diverse activities as needed, and when appropriate, including Clinical Development activities (e.g., contributing to the development of an IND for a preclinical asset, etc), Business Development activities (e.g., contributing to Search and Evaluation efforts, Diligence, etc), or other non-clinical departmental activities.
- Other related duties as assigned.
Qualifications
- Advanced degree such as PhD, Pharm D, MD or equivalent is preferred and +5 years directly related experience in a clinical development-biopharmaceutical environment, or the equivalent combination of education and experience.
- Demonstrated skills and understanding in Phase 1-3 clinical trial design and data interpretation; experience with oncology clinical trials is required.
- Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices (GCP), ICH Guidelines, is required.
- Familiarity with the drug approval process through NDA or BLA or ex-US drug approval process is preferred.
- Sufficient content expertise and prior experience to be able to be a key contributor to document development such as INDs, Protocols, ICFs, IBs and regulatory submission package (NDA/MAA), under the direction and oversight of the VP, Clinical Development.
- Sufficient scientific knowledge and prior experience to play a lead role in the process of clinical study data review and interpretation.
- Proven track record of successfully delivering projects on time, to budget and the required quality.
- Excellent interpersonal, verbal and written communication skills.
- Team player, with the ability to move in a fast paced and dynamic environment.
- Ability to build and maintain effective internal and external professional relationships.
- Ability to travel approximately 25% of the time.
The anticipated salary range for this role is $160,000 – $200,000