Associate Director, Drug Safety Physician
Rigel Pharmaceuticals Inc.
August 12, 2026
Remote friendly (South San Francisco, CA)
United States
Medical Affairs
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.
Responsibilities
- Perform comprehensive medical review of ICSRs (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).
Qualifications / Skills
- 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.
Benefits
- 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.
- 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.
Responsibilities
- Perform comprehensive medical review of ICSRs (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).
Qualifications / Skills
- 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.
Benefits
- 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.