Clinical Research Director

Sanofi•Cambridge, MA

2d•$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. Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

MD degree or equivalent.
Hematology/Oncology fellowship or minimum 4 years experience in Oncology Development.
Expertise in pharmaceutical medicine based on minimum 3 years industry or academic clinical research experience.
Demonstrated ability to interact productively with external investigators.
Demonstrated ability to work with a multifunctional team to achieve project milestones.
Understanding of and willingness to meet applicable regulatory, quality and compliance standards.

Nice To Haves

Experience in late-stage clinical development preferred.

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.
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.