Safety Physician, Medical Director

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