Sanofi

Biopharma

ClinicalResearchDirector

€76–101k Vitry-sur-Seine, France FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Clinical Research Director at Sanofi. Skills: Clinical trial strategy, Oncology, Clinical development. Establish clinical development plan. Adapt clinical development plan”

Industry & Context.

Biopharma

What They're Looking For.

Must Have

Oncology training required, MD with 4+ years experience required, Pharmaceutical experience required, Demonstrated clinical trial design experience, Demonstrated clinical trial execution experience, Proven track record with multifunctional teams, Fluency in English required

Nice to Have

3+ years pharmaceutical experience preferred, Experience in late-stage clinical development preferred, Excellence in academic clinical research considered, French language nice to have, Spanish language nice to have

What You'll Do.

Establish clinical development plan

Adapt clinical development plan

Discuss with investigators

Discuss with advisors

Discuss with regulatory authorities

Lead execution of clinical development

Oversee execution of clinical studies

Author abbreviated protocol

Review final protocol

Review protocol amendments

Review Informed Consent Form

Review Written Subject Information

Review Trial Disclosure Form

Review study specific committee charters

Lead study specific committees

Lead clinical interpretation of study results

Contribute to clinical study reports

Contribute to clinical summaries

Provide clinical guidance to functions

Participate in regulatory documents

Contribute to safety documents

Review Investigator Brochure

Contribute Investigator Brochure

Contribute IND filings

Contribute IMPD filings

Review development risk management plans

Contribute development risk management plans

Contribute clinical sections of NDA

Contribute clinical sections of CTD

Contribute clinical sections of Briefing packages

Contribute clinical sections of PSP

Contribute clinical sections of PIP

Author clinical abstracts

Author presentations for conferences

Support planning of advisory board meeting

Present development strategy

Discuss development strategy

Present clinical study results

Discuss clinical study results

How You'll Work.

Team & Collaboration

Multifunctional teams; Clinical development team; Clinical Operations; Biostatistics; Regulatory; Translational Medicine; Project Management; New Product Planning; Pharmacovigilance

Communication Scope

External investigator interaction; Advisory board presentations

Process & Methodology

Project management

Full Job Description

_Clinical Research Director – Job description_ **Job title:** Clinical Research Director * **Location :** Vitry-sur-Seine, France * **Hiring Manager :** Ray Perez _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,

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