Clinical Research Director
Sanofi
August 29, 2026
On-site
Morristown, NJ
$206,250 - $343,750 USD yearly
Clinical Research and Development
Main Responsibilities
- Establishes or adapts clinical development plan for program(s), including discussions with clinical investigators, advisors, and regulatory authorities; plans contingencies.
- Leads, supports, and oversees execution of clinical development/study activities:
- Authors abbreviated protocol; reviews final protocol and protocol amendments.
- Reviews informed consent, written subject information, and trial disclosure forms.
- Reviews study-specific committee charters; leads study-specific committees with operational support.
- Leads clinical interpretation of study results; contributes to clinical study reports and clinical summaries.
- Provides clinical guidance to Clinical Operations, Biostatistics, and Translational Medicine.
- Participates in regulatory and safety documents/discussions:
- Reviews/contributes clinical sections of Investigator Brochure, IND/IMPD filings, DSUR, and development risk management plans.
- Contributes clinical sections of NDA/CTD, regulatory meeting briefing packages, and PSP/PIP.
- Participates in Advisory Committee preparation.
Scientific Data Evaluation and Authorship
- Authors clinical abstracts, conference presentations, and manuscripts (as appropriate).
- Supports advisory board planning; presents/discusses development strategy and clinical study results with external investigators/advisory boards.
Qualifications
- MD degree or equivalent.
- Hematology/Oncology fellowship or minimum 4 years oncology development experience.
- Minimum 3 years industry or academic clinical research experience in pharmaceutical medicine.
- Late-stage clinical development experience preferred.
- Demonstrated ability to interact with external investigators and work in multifunctional teams.
- Understanding of and willingness to meet applicable regulatory, quality, and compliance standards.
Benefits
- High-quality healthcare and prevention/wellbeing programs; at least 14 weeks’ gender-neutral parental leave.
- Establishes or adapts clinical development plan for program(s), including discussions with clinical investigators, advisors, and regulatory authorities; plans contingencies.
- Leads, supports, and oversees execution of clinical development/study activities:
- Authors abbreviated protocol; reviews final protocol and protocol amendments.
- Reviews informed consent, written subject information, and trial disclosure forms.
- Reviews study-specific committee charters; leads study-specific committees with operational support.
- Leads clinical interpretation of study results; contributes to clinical study reports and clinical summaries.
- Provides clinical guidance to Clinical Operations, Biostatistics, and Translational Medicine.
- Participates in regulatory and safety documents/discussions:
- Reviews/contributes clinical sections of Investigator Brochure, IND/IMPD filings, DSUR, and development risk management plans.
- Contributes clinical sections of NDA/CTD, regulatory meeting briefing packages, and PSP/PIP.
- Participates in Advisory Committee preparation.
Scientific Data Evaluation and Authorship
- Authors clinical abstracts, conference presentations, and manuscripts (as appropriate).
- Supports advisory board planning; presents/discusses development strategy and clinical study results with external investigators/advisory boards.
Qualifications
- MD degree or equivalent.
- Hematology/Oncology fellowship or minimum 4 years oncology development experience.
- Minimum 3 years industry or academic clinical research experience in pharmaceutical medicine.
- Late-stage clinical development experience preferred.
- Demonstrated ability to interact with external investigators and work in multifunctional teams.
- Understanding of and willingness to meet applicable regulatory, quality, and compliance standards.
Benefits
- High-quality healthcare and prevention/wellbeing programs; at least 14 weeks’ gender-neutral parental leave.