Safety Physician, Medical Director
On-site in San Diego
MD requirement w/ board certification
Safety Physician, Drug Safety (Pharmacovigilance) – Clinical
Company Overview: Our client is a clinical-stage biotechnology company based in San Diego, CA, focused on developing life-saving therapeutics through cutting-edge science. The company has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA, with a growing pipeline of therapeutics spanning genetic, cardiometabolic, complement-mediated, and central nervous system diseases.
Job Description: The Safety Physician is responsible for providing medical oversight and strategic leadership in pharmacovigilance across clinical-stage programs (Phase I–III). This role ensures patient safety through proactive signal detection, risk assessment, and benefit-risk evaluation, while supporting regulatory compliance and high-quality safety deliverables.
The Safety Physician will partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Biostatistics to integrate safety insights into ongoing and future clinical programs.
Essential Responsibilities:
- Provide medical review and assessment of adverse events (AEs), serious adverse events (SAEs), and other safety data from clinical trials
- Perform ongoing safety surveillance and signal detection across Phase I–III programs
- Lead benefit-risk assessments and contribute to safety-related decision-making
- Collaborate with Clinical Development on protocol design, including safety monitoring plans and stopping rules
- Review clinical protocols, investigator brochures, and informed consent documents for safety content
- Support Data Monitoring Committees (DMCs) and Safety Review Committees (SRCs) as needed
- Contribute to the preparation and review of aggregate safety reports (e.g., DSURs, IND annual reports, safety narratives)
- Ensure compliance with global pharmacovigilance regulations and internal SOPs
- Support regulatory submissions and interactions with health authorities (e.g., FDA, EMA)
- Identify, evaluate, and communicate emerging safety signals
- Contribute to risk management strategies, including Risk Management Plans (RMPs) and mitigation activities
- Maintain oversight of safety profiles across the clinical portfolio
- Partner with Clinical Operations, Data Management, Biostatistics, and Regulatory teams to ensure accurate and timely safety data review
- Provide safety input into clinical study reports (CSRs), publications, and internal governance meetings
- Serve as a medical resource for safety-related inquiries across the organization
Qualifications:
- MD (or equivalent medical degree) with board certification; required
- 5+ years of experience in pharmacovigilance and/or clinical development within biotech/pharma
- Experience supporting clinical trials across Phases I–III
- Strong understanding of global safety regulations and reporting requirements
Skills & Expertise:
- Expertise in safety signal detection, risk assessment, and benefit-risk evaluation
- Strong knowledge of GCP, ICH guidelines, and pharmacovigilance practices
- Excellent analytical and clinical judgment skills
- Effective communicator with the ability to clearly convey complex safety information
