Senior Medical Director- Early Development Oncology
$182,000–$346,000 year
HybridFlorham Park, New Jersey, United States
Florham Park, New Jersey, United StatesHybridFull Time$182,000–$346,000 yearSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
Conduct safety surveillance for oncology products by interpreting pharmacovigilance regulations and analyzing aggregate clinical data. Lead strategy for key documents including medical safety assessments, risk management plans, and NDA/sNDA submission safety components. Collaborate with cross-functional teams to guide dose selection, inclusion criteria, and periodic reports like DSURs and PSURs. Implement risk management strategies and author technical documents while mentoring team members. Interpret regulations to support patient safety activities throughout the product lifecycle.
Required Qualifications
- MD / DO
- 2+ years of internal medicine residency with patient management experience
- PhD or Clinical Pharmacology fellowship
- 2-5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
- Oncology experience
- Ability to lead cross-functional teams in a collaborative environment
Desired Qualifications
- PhD or Clinical Pharmacology fellowship
- Oncology experience
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.