Sr. Director, Clinical Scientist at Replimune Group in Woburn

Job description

Overview Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves. Join us, as we reshape the future. The Senior Director, Clinical Development/Clinical Scientist will report to the VP or Executive Director, of the Early Clinical Development team to ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Senior Director, Early Clinical Development will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. The Senior Director, Early Clinical Development will play a key role in the establishment and growth of Clinical Development functions to assure best-in-class global capabilities and execution. Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biometrics, translational medicine, and program leadership. This position can be based either in our Woburn office or be a remote role • Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 30% travel to our Woburn HQ, or as business needs require. Key responsibilities: · Facilitate and execute the generation, author, update, and/or review of key clinical and regulatory documents, including, but not limited to: o Protocol concepts, synopses, protocols, and amendments o Informed consent documents o Investigator Brochures o Clinical study reports o Abstracts, posters and manuscripts o Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports o Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports o Risks / benefits analysis for applicable documents o Clinical study supporting documentations and processes, e.g. charters for (independent) safety data monitoring or steering committee, study specific management plans and manuals, SOPs, etc. · Instrumental to the Early Clinical Development Plan Generation and Program Strategy · Primary contact and lead for all clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation and documentation of clinical studies. Partner with relevant functional areas for the successful implementation and execution of clinical studies. Specific tasks will include but are not limited to the following: o Provide clinical and scientific expertise for selection of investigator and vendors o Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol o Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs o Review, query, and analyze clinical trial data o Serve as medical monitor or partner with (senior) medical director on medical monitoring, patient eligibility and study treatment related questions, in cooperation with the CRO or directly with study investigator · Interpret, and present clinical