Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience
Ladders · Princeton, NJ · 5 days ago
On-siteManagement$335k–$406k/yrFull-time
Responsibilities
- Provide strategic oversight for medical safety assessments by managing the safety physician team
- Chair the Safety Management Team and oversee safety activities and benefit-risk strategies for assigned compounds
- Approve and review safety documentation, including aggregate safety review documents and clinical trial safety sections
- Guide strategy for signal evaluation and ensure proper documentation of safety signals
- Drive organizational changes and adopt new processes to enhance pharmacovigilance procedures
- Support regulatory inspections and manage compliance with safety-related issues
Qualifications
- MD or equivalent required; postgraduate qualification in internal medicine, immunology, oncology, or related specialty preferred
- 7+ years in pharmacovigilance or relevant pharmaceutical field preferred; management experience strongly preferred
- Strong consideration for clinical research, observational research, or clinical practice experience
- Extensive understanding of drug development processes and regulatory requirements for safety assessment
- Expertise in pharmacovigivalence with ability to apply knowledge to evaluate safety concerns
Benefits
- Comprehensive health coverage including medical, dental, and vision care
- Wellbeing support programs such as employee assistance and wellness resources
- Financial protection benefits like 401(k), life insurance, and disability insurance
- Flexible paid time off, including unlimited vacation with manager approval and numerous paid holidays
- Global shutdown period between Christmas and New Year, with additional paid volunteer days and various parental leave options