Director/Senior Director, Head of Global Patient Safety Science
Structure Therapeutics
14 days ago
Remote friendly (South San Francisco, CA)
United States
Medical Affairs
Position Summary
Senior Director, Global Patient Safety Science
Responsibilities
- Provide strategic leadership for safety science: integrated safety surveillance, signal detection, signal assessment, aggregate review, and benefit-risk evaluation.
- Shape safety strategy across early- to late-phase clinical development.
- Lead cross-functional safety governance (e.g., Signal Management Committees), ensuring documentation and escalation of key risks.
- Interpret safety data across sources (case reports, aggregate datasets, studies, literature, external data).
- Oversee individual case review, Analysis of Similar Events, signal tracking, and escalation pathways.
- Oversee preparation/quality of core safety deliverables (e.g., DSURs, Reference Safety Information, safety sections of IB/protocols/ICFs, clinical study reports, regulatory responses).
- Represent Safety Science on program teams and with external partners/regulators.
- Partner on health authority interactions, inspection readiness, and submission safety strategies.
- Build and improve pharmacovigilance processes, SOPs, standards, and tools.
- Oversee CROs/safety providers; evaluate fit-for-purpose systems/analytics/digital capabilities.
- Influence decisions by translating safety data into recommendations; identify risks and drive mitigations.
- Mentor colleagues (no formal people management required).
Required/Preferred Skills & Qualifications
- MD/DO/PharmD (or equivalent).
- 5+ years drug safety/pharmacovigilance in clinical development; 3+ years in safety science with strategic responsibility.
- Deep knowledge of global pharmacovigilance regulations/ICH, signal detection, aggregate reporting, benefit-risk.
- Strong clinical judgment; ability to communicate complex safety data.
- Experience with safety governance and regulatory authority interactions/inspection readiness; NDA/BLA/MAA support strongly preferred.
- Experience overseeing CROs/vendors; familiarity with Argus/Veeva Safety/Spotfire; working knowledge of MedDRA/SMQs/ASEs.
- Oral small molecules and/or metabolic therapeutic expertise is a plus.
Benefits (as stated)
Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision insurance; 401(k) match; unlimited PTO; paid holidays (including winter shutdown).
Application instructions
Apply through the official career page at BambooHR.
Senior Director, Global Patient Safety Science
Responsibilities
- Provide strategic leadership for safety science: integrated safety surveillance, signal detection, signal assessment, aggregate review, and benefit-risk evaluation.
- Shape safety strategy across early- to late-phase clinical development.
- Lead cross-functional safety governance (e.g., Signal Management Committees), ensuring documentation and escalation of key risks.
- Interpret safety data across sources (case reports, aggregate datasets, studies, literature, external data).
- Oversee individual case review, Analysis of Similar Events, signal tracking, and escalation pathways.
- Oversee preparation/quality of core safety deliverables (e.g., DSURs, Reference Safety Information, safety sections of IB/protocols/ICFs, clinical study reports, regulatory responses).
- Represent Safety Science on program teams and with external partners/regulators.
- Partner on health authority interactions, inspection readiness, and submission safety strategies.
- Build and improve pharmacovigilance processes, SOPs, standards, and tools.
- Oversee CROs/safety providers; evaluate fit-for-purpose systems/analytics/digital capabilities.
- Influence decisions by translating safety data into recommendations; identify risks and drive mitigations.
- Mentor colleagues (no formal people management required).
Required/Preferred Skills & Qualifications
- MD/DO/PharmD (or equivalent).
- 5+ years drug safety/pharmacovigilance in clinical development; 3+ years in safety science with strategic responsibility.
- Deep knowledge of global pharmacovigilance regulations/ICH, signal detection, aggregate reporting, benefit-risk.
- Strong clinical judgment; ability to communicate complex safety data.
- Experience with safety governance and regulatory authority interactions/inspection readiness; NDA/BLA/MAA support strongly preferred.
- Experience overseeing CROs/vendors; familiarity with Argus/Veeva Safety/Spotfire; working knowledge of MedDRA/SMQs/ASEs.
- Oral small molecules and/or metabolic therapeutic expertise is a plus.
Benefits (as stated)
Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision insurance; 401(k) match; unlimited PTO; paid holidays (including winter shutdown).
Application instructions
Apply through the official career page at BambooHR.