Senior Medical Director - Patient Safety

📋 Description

• Lead safety strategy for late-stage oncology products
• Oversee pharmacovigilance activities across lifecycle
• Collaborate with cross-functional teams for dose and safety monitoring
• Lead safety components of NDA/sNDA submissions and responses
• Provide regulatory guidance and risk management planning
• Mentor team and contribute to publications

🎯 Requirements

• MD/DO with 2+ years internal medicine residency; additional PhD/Pharmacology fellowship preferred
• 2-5 years Pharmacovigilance/Clinical Development in pharma
• Regulatory submission experience (IND/BLA) required
• Oncology patient safety experience required
• Ability to lead cross-functional teams and communicate findings
• Strong written and analytical skills

🎁 Benefits

• Competitive compensation package
• Comprehensive benefits (health, dental, vision, 401(k))
• Long-term incentive participation
• Equal opportunity employer