Associate Director, Drug Safety Physician

Position Summary

• Serve as a subject matter expert and thought leader for drug safety activities across the portfolio, applying oncology drug development, precision medicine biomarkers, and global regulatory frameworks.

• Perform comprehensive medical review of ICSSs (clinical trials and post-marketing): assess significance, seriousness, expectedness, and causality; provide medical causality assessments for SAEs/SUSARs; review medical narratives and ensure documentation accuracy.
• Analyze similar cases and conduct case series evaluations to support signal detection and regulatory decision-making.
• Provide medical guidance to case processing teams and ensure compliance with global pharmacovigilance regulations.
• Review aggregate safety data in standardized regulatory reports (e.g., Investigator Brochures, DSURs, PBRERs, PSURs) to support balanced medical presentation and signal detection.
• Ensure appropriate MedDRA and WHO-DD coding with CRO/DSPV teams.
• Coordinate submission of expedited and periodic safety reports to regulators and required distribution to partners.
• Oversee set-up of new safety projects, including study-specific Safety Management Plans and safety systems/processes.
• Lead safety data analysis and signal management; conduct advanced signal detection integrating preclinical, clinical, and literature data.
• Author/review complex safety documents (e.g., IND Annual Reports, PADERs, DSURs, PSURs, integrated safety summaries) and safety sections of clinical/regulatory submissions.
• Lead department operations (procedures, training, service provider oversight, audit preparation) and develop departmental policies across jurisdictions.
• Lead cross-functional liaison and represent Drug Safety in clinical team meetings.
• Solve complex safety problems and drive innovative monitoring approaches for novel modalities (e.g., ADCs).

• MD or equivalent advanced degree required.
• 8–12+ years progressive drug safety/pharmacovigilance experience in biopharma.
• 3–4+ years in leadership roles managing safety teams.
• Oncology drug development and precision medicine expertise; experience with targeted/bio marker‑driven development and novel modalities.
• Deep knowledge of global pharmacovigilance regulations (ICH, FDA, EMA, GVP) and precision medicine guidance.
• Advanced expertise in safety signal detection and benefit‑risk assessment; ability to integrate biomarker data into safety monitoring.
• Strong written/verbal communication; ability to influence stakeholders.
• Experience interfacing with regulatory authorities; biotech/pharma experience with marketed products.

• Eligible for annual bonus and equity incentive awards (not commission‑based).
• Comprehensive benefits: medical/dental/vision, life/disability, flexible spending, 401(k), paid time off, paid holidays, and other benefits.