Senior Clinical Research Director
Sanofi
August 07, 2026
Remote friendly (Morristown, NJ)
United States
$236,250 - $393,750 USD yearly
Clinical Research and Development
Senior Clinical Research Director (sCRD)
Role responsibilities:
- Serve as primary clinical expert; report to Global Project Head (GPH) or Principal Clinical Lead (PCL) and coordinate with CRDs, Pharmacovigilance, Regulatory, and key stakeholders.
- Provide medical expertise for clinical studies/registries (e.g., protocol, Key Results, Clinical Study Report) and support feasibility, medical data review/validation, and study risk assessment.
- Contribute to Extended synopsis and Protocol; clinical sections of submission dossiers (CTD for FDA/EMA, filings in Japan/China, responses to health authorities).
- Lead clinical development plan: clinical development plans and IDP sections; resolve study issues via action plans; raise issues to GPH/PCL; develop clinical value proposition/TPP/market access strategy (clinical perspective); evaluate competitive medical literature.
- Oversee execution: review/validate protocols and amendments; review ICF WSI and TDF; manage timelines/budgets/risk in compliance with GCP/SOPs; lead study committees; co-develop SAP; prepare key results and clinical study report.
- As needed: develop abbreviated/final protocols; support feasibility; review clinical inputs across study documents (ICF/CRF/e-diary/monitoring plan); review/approve study documents; support investigator meeting materials; provide continuous aggregated data medical review; answer EC/IRB/site medical questions.
- Contribute to regulatory/safety documents (IB, CTA, IND, DSUR, INDAR, DRMP, RMP; BLA/CTD, briefing packages, PSP/PIP) and advisory committee preparation.
Qualifications/skills:
- MD or equivalent; Medical Oncology or Hematology/Oncology specialist.
- At least 4 years in pharma/biotech clinical development.
- Fluent English (spoken/written) and strong communication.
- Strong scientific/medical expertise; clinical development methodology; risk-management mindset; ability to negotiate resources; work in matrix; teaching/training ability; international/intercultural skills; computer skills; open to digital solutions.
Benefits (as stated):
- High-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
Role responsibilities:
- Serve as primary clinical expert; report to Global Project Head (GPH) or Principal Clinical Lead (PCL) and coordinate with CRDs, Pharmacovigilance, Regulatory, and key stakeholders.
- Provide medical expertise for clinical studies/registries (e.g., protocol, Key Results, Clinical Study Report) and support feasibility, medical data review/validation, and study risk assessment.
- Contribute to Extended synopsis and Protocol; clinical sections of submission dossiers (CTD for FDA/EMA, filings in Japan/China, responses to health authorities).
- Lead clinical development plan: clinical development plans and IDP sections; resolve study issues via action plans; raise issues to GPH/PCL; develop clinical value proposition/TPP/market access strategy (clinical perspective); evaluate competitive medical literature.
- Oversee execution: review/validate protocols and amendments; review ICF WSI and TDF; manage timelines/budgets/risk in compliance with GCP/SOPs; lead study committees; co-develop SAP; prepare key results and clinical study report.
- As needed: develop abbreviated/final protocols; support feasibility; review clinical inputs across study documents (ICF/CRF/e-diary/monitoring plan); review/approve study documents; support investigator meeting materials; provide continuous aggregated data medical review; answer EC/IRB/site medical questions.
- Contribute to regulatory/safety documents (IB, CTA, IND, DSUR, INDAR, DRMP, RMP; BLA/CTD, briefing packages, PSP/PIP) and advisory committee preparation.
Qualifications/skills:
- MD or equivalent; Medical Oncology or Hematology/Oncology specialist.
- At least 4 years in pharma/biotech clinical development.
- Fluent English (spoken/written) and strong communication.
- Strong scientific/medical expertise; clinical development methodology; risk-management mindset; ability to negotiate resources; work in matrix; teaching/training ability; international/intercultural skills; computer skills; open to digital solutions.
Benefits (as stated):
- High-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.