Clinical Research Director

Sanofi•Cambridge, MA

1d•$206,250 - $343,750•Hybrid

About The Position

Join the engine of Sanofi’s 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. Reporting to the Global Project Head, the CRD leads clinical trial strategy of assigned program(s) within the clinical development team, including interactions with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan. The clinical development team further develops a compound through life cycle management.

Requirements

MD degree or equivalent.
Minimum 3 years industry or academic clinical development experience
Hematology/Oncology experience preferred
Demonstrated ability to work with a multifunctional team to achieve project milestones
Understanding of and willingness to meet applicable regulatory, quality and compliance standards

Responsibilities

Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.
Leads, supports and oversees the execution of clinical development and studies activities, including but not limiting to: Authors abbreviated protocol. Reviews the final protocol and protocol amendments. Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form. Reviews the study specific committee charters. Leads study specific committees with operational support.
Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries.
Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine
Participates and contributes to regulatory and safety documents and discussions
Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans
Contributes to the clinical sections of the NDA/CTD, Briefing packages for regulatory meetings, PSP/PIP
Participates in Advisory Committee preparation
Scientific data evaluation and authorship
Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate
Supports the planning of advisory board meeting.
Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate