Clinical Research Director - Oncology, AI-Driven Trials

Sanofi; Cambridge, Northern (MA, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Sanofi in Cambridge, MA is seeking a Clinical Research Director to lead late-stage oncology development, shaping development plans and coordinating with investigators and regulatory authorities. You will guide cross-functional teams across Clinical Operations, Biostatistics and Translational Medicine to ensure robust, compliant study execution.

The role requires an MD with oncology development experience and a proven track record working with external investigators, regulators, and advisory

Qualifications

• MD degree or equivalent required.
• Hematology/Oncology fellowship or 4+ years in Oncology Development preferred.
• 3+ years industry or academic clinical research experience in pharmaceutical medicine.
• Experience in late-stage clinical development preferred.
• Proven ability to interact productively with external investigators.
• Ability to work with multifunctional teams to meet project milestones.
• Understanding of regulatory, quality and compliance standards.

Responsibilities

• Establishes or adapts clinical development plan for the programs with investigators, advisors and regulatory authorities and plans contingencies.
• Leads and oversees execution of clinical development and studies activities, including protocol terminology, amendments and consent forms.
• Reviews study-specific committees' charters and leads related committees with operational support.
• Leads clinical interpretation of study results and contributes to reports and summaries.
• Provides clinical guidance to Clinical Operations, Biostatistics, and Translational Medicine.
• Contributes to regulatory and safety documents (Investigator Brochure, IND/IMPD, DSUR, risk management plans).
• Authors clinical abstracts, conference presentations and manuscripts when appropriate.

Skills

Clinical research

Regulatory strategy

Cross-functional collaboration

External investigators liaison

Late-stage development

Oncology development

Education

MD degree or equivalent

Hematology/Oncology fellowship

Job description

Sanofi in Cambridge, MA is seeking a Clinical Research Director to lead late-stage oncology development, shaping development plans and coordinating with investigators and regulatory authorities. You will guide cross-functional teams across Clinical Operations, Biostatistics and Translational Medicine to ensure robust, compliant study execution.

The role requires an MD with oncology development experience and a proven track record working with external investigators, regulators, and advisory