Sanofi
Biopharma
ClinicalResearchDirector
Neural analysis suggests this role is
optimal for Director candidates.
“Clinical Research Director at Sanofi. Skills: Clinical trial strategy, Clinical development, Oncology. Establish clinical development plan. Adapt clinical development plan”
Industry & Context.
What They're Looking For.
Must Have
Oncology training required, MD with experience (4+ years) required, Pharmaceutical experience required, Fluency in English required
Nice to Have
3+ years pharmaceutical experience preferred, Experience in late-stage clinical development preferred, 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 development
Lead execution of clinical studies
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
Participate in regulatory documents
Contribute to regulatory documents
Participate in safety discussions
Contribute to safety discussions
Review Investigator Brochure
Contribute Investigator Brochure
Review IND/IMPD filings
Contribute IND/IMPD filings
Review development risk management plans
Contribute development risk management plans
Contribute clinical sections of NDA/CTD
Contribute clinical sections of Briefing packages
Contribute clinical sections of PSP/PIP
Participate in Advisory Committee preparation
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
Public speaking
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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