AI-Driven Clinical Development Director

Sanofi; Morristown (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

Sanofi in Cambridge, MA is seeking a senior clinical development leader in Oncology to drive late-stage programs. You will design development plans, engage with investigators, advisors and regulators, and oversee studies to advance breakthrough therapies.

You will author protocols and abstracts, interpret study results, and collaborate across Clinical Operations, Biostatistics and Translational Medicine to ensure rigorous execution and regulatory readiness.

Qualifications

• MD degree or equivalent required.
• Fellowship in Hematology/Oncology preferred or 4+ years in Oncology Development.
• Expertise in pharmaceutical medicine with 3+ years clinical research.

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.
• 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.

Skills

Oncology development experience

Regulatory understanding

External investigator interaction

Education

MD degree or equivalent

Hematology/Oncology fellowship (preferred)

Job description

Sanofi in Cambridge, MA is seeking a senior clinical development leader in Oncology to drive late-stage programs. You will design development plans, engage with investigators, advisors and regulators, and oversee studies to advance breakthrough therapies.

You will author protocols and abstracts, interpret study results, and collaborate across Clinical Operations, Biostatistics and Translational Medicine to ensure rigorous execution and regulatory readiness.