Safety Physician, Medical Director

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.

• 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