Regulatory Leader

Turnstone Biologics is a clinical-stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach to TIL therapy. Turnstone’s innovative TIL therapy is based upon the identification, selection, and expansion of the most potent tumor-reactive T cells, known as Selected TILs, and is designed to overcome the limitations of first-generation bulk TILs that have demonstrated objective responses only in limited tumor types. Turnstone’s most advanced program, TIDAL-01, is currently being evaluated in two Phase 1 studies in patients with melanoma, breast cancer and colorectal cancer, and the Company is also actively advancing its preclinical pipeline programs including TIDAL-02, its next Selected TIL program, and its TIDAL-01 and viral immunotherapy combination program.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. If you are a passionate person, and our science excites you – this opportunity may be for you.Position OverviewWe are seeking an innovative, highly motivated, versatile leader to join us as our Clinical Regulatory Leader. This role will report to the Vice President, Clinical Development and will be the regulatory representative at various core teams. The successful candidate will be results-driven and a highly skilled Clinical Regulatory Leader with extensive experience in guiding regulatory strategies and ensuring compliance for pharmaceutical and biotechnology companies. The ideal candidate will be adept at navigating the complex landscape of regulatory affairs, and have a proven track record of successfully leading cross-functional teams to achieve regulatory milestones and approvals.This is both a strategic and execution focused role requiring someone to see the big picture, plan, and roll up their sleeves and get things done. This role requires proven leadership to effectively communicate, coordinate, and collaborate cross-functionally with Clinical Operations, External Manufacturing, Quality, Technical Operations, Research, Finance, IT and Commercial teams.KEY RESPONSIBILITIESProvide expert, technical and professional advice, guidance and leadership to the Company on Regulatory Affairs matters.Proactively participate in design of global regulatory strategies for the development of cell therapy products.Serve as one of the primary liaison between Turnstone and all strategic partners/partner companies in regulatory topics/issues.Plan, oversee and manage preparation and submissions (including but not limited to pre-IND, Initial IND/CTA and amendments, Safety reporting, BLA, Orphan drug designation); this will require strong regulatory knowledge and understanding of the underlying science, cross-functional interactions, and excellent project management and writing skills.Participate in interactions with regulatory agencies to solidify strategy and address regulatory comments.Lead preparation of agency meetings and actively participate in scheduled meetings.Drive adherence to regulatory requirements and guidelines.Perform regulatory intelligence activities – monitor regulation changes and competitor trends/strategy.Provide regulatory input regarding budget.With Clinical Operations and Quality Assurance, ensure compliance of Clinical Development with GCPs and SOPs and other relevant regulations.Review and approve departmental and Clinical SOPs and revisions.Manage all relevant contract relationships.Maintain a thorough understanding of GCPs, internal SOPs, and guidance documents issued by various regulatory agencies, including the US-FDA, EMA, and ICH.Maintain a regulatory document system.PROFESSIONAL EXPERIENCE/QUALIFICATIONSDegree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience.Regulatory Affairs Certification (RAC) preferred.Background ideally oncology cell therapy or biologics.8 + year experience with PhD; 10+ years with Masters or bachelor’s degrees.Proven track record of managing critical projects as a part of an interdisciplinary team.Proven track record of representing the department in project teams, committees and external meetings.Prior experience managing regulatory submissions to deadlines.Thorough understanding of relevant drug development regulations and guidelines.Outstanding interpersonal and communication (written and verbal) skills.Effective task planning and coordination abilities.Proficiency with computer and standard software programs (Microsoft Office, PowerPoint and Excel).COMPENSATIONAn attractive compensation package commensurate with this senior leadership role will be provided.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.Apply for this job#J-18808-Ljbffr