Senior Clinical Research Director - Oncology
BioSpace · Cambridge, MA · 2 wk ago
On-siteAnalystFull-time
About the role
Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.
Main Responsibilities
- Working within a matrix model, establish or adapt clinical development and contingency plans by engaging with clinical investigators, advisors and regulatory authorities.
- Author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD filings, annual reports, development risk management plans.
- Lead the clinical interpretation of study results
- Contributes to clinical study reports and clinical summaries, including regulatory submissions.
- Provide expert medical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine, to ensure optimal planning and execution of clinical trials.
- Present and discuss development strategy and clinical study results with key internal stakeholders, external investigators, advisory boards, and regulatory authorities.
- Author clinical abstracts, presentations for conferences, and manuscripts.
About You
- Education: Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies is a plus.
- Experience: At least 4 years experience in clinical development in the pharmaceutical industry, CRO, or healthcare institution.
- Soft skills: Excellent communication skills (verbal and written English) with both internal and external stakeholders; adept at problem solving; thoughtful risk-taking; demonstrated ability to work with a multi-functional team to achieve project milestones; understanding of and willingness to meet applicable regulatory, quality and compliance standards; quality-focused, adept at developing good practices, open-minded to data-driven approaches and new digital solutions; international/intercultural working skills.