Sr. Medical Director

📋 Description

• Experienced safety physician supporting clinical development and postmarketing safety strategy for assigned products.
• Responsible for all safety evaluation and risk management activities.
• Establish safety strategy, core safety information, local labeling, safety reporting, benefit-risk evaluation, risk management, regulatory engagement, and responses to inquiries.
• Prepare Safety Management Committee materials and other internal/external committees for designated products.
• Medical review of adverse event reports and ensure timely expedited reporting in compliance with regulations.
• Ensure project timelines and inspection readiness.

🎯 Requirements

• Medical Degree
• At least 12 years of drug safety and pharmacovigilance experience with ≥3 years of oversight/management.
• Extensive experience with safety signal evaluation, data review/analysis, cross-functional collaboration, regulatory correspondence, and safety labeling updates.
• Experience in both clinical development and post-marketing safety.
• Experience with regulatory submissions for NDAs, EU MAAs, and other countries’ regulatory reviews.
• Demonstrated ability to manage drug safety teams or CSOs for postmarketing with expedited reporting and PBRER preparation.

🎁 Benefits

• Salary: $325,000 – $370,000 USD
• Market leading compensation
• 401K with 100% employer match on first 3% and 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals