Sanofi
biopharma
ClinicalResearchDirector
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“Clinical Research Director at Sanofi. Skills: clinical trial strategy, clinical development plan, clinical development and studies activities, clinical interpretation of study results, regulatory and safety documents and discussions, scientific data evaluation and authorship. Leads clinical trial strategy of assigned program(s) within the clinical development team. Establishes or adapts clinical development plan for the program(s)”
What You'll Achieve.
drive breakthroughs that could turn the impossible into possible for millions; achieve project milestones
Industry & Context.
plans contingencies
What They're Looking For.
Must Have
MD degree or equivalent, with Medical Oncology fellowship., Hematology/Oncology fellowship or experience (4+ years) in Oncology Development, Expertise in pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years), Experience in clinical development, late-stage preferred, 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
What You'll Do.
Leads clinical trial strategy of assigned program(s) within the clinical development team
Establishes or adapts clinical development plan for the program(s)
supports and oversees the execution of clinical development and studies activities
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
Participates and contributes to regulatory and safety documents and discussions
Authors clinical abstracts
presentations for conferences
Supports the planning of advisory board meeting
Presents and discusses development strategy and clinical study result with external investigators and advisory boards
How You'll Work.
Team & Collaboration
interactions with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance; work with a multifunctional team to achieve project milestones; Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine
Communication Scope
interactions with clinical investigators, advisors and regulatory authorities; Provides effective clinical guidance to other functions; Participates in Advisory Committee preparation; Presents and discusses development strategy and clinical study result with external investigators and advisory boards
Process & Methodology
clinical development plan, execution of clinical development and studies activities
Full Job Description
**Job Title:** Clinical Research Director **Location:** Cambridge, MA, Morristown, NJ**** **About the Job** 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. **About Sanofi:** We’re 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. _**Main 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 Translati
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