Clinical Research Director

Clinical Research Director

Sanofi

Vitry-sur-Seine, France

About the job

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.

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 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

About you

Experience

• Oncology training (medical oncology or hematology/oncology fellowship) or MD with experience (4+ years) is required.
• Pharmaceutical experience is required, 3+ years strongly preferred.
• Experience in late-stage clinical development strongly preferred.
• Demonstrated experience in clinical trial design and execution.
• Proven track record of working effectively with multifunctional teams to achieve project milestones.
• While industry experience is preferred, candidates with demonstrated excellence in academic clinical research and documented achievements may be considered with relatively less industry experience.

Soft and Technical Skills

• Deep understanding of oncology, particularly solid tumor biology
• 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

Education

• Oncology training (medical oncology or hematology/oncology fellowship) or MD with experience (4+ years) is required.

Languages

• Fluency in spoken and written English required (for global collaboration with US and European teams). French: Not required (nice to have for France-based positions). Spanish: Not required (nice to have for Spain-based positions).