Director/Sr. Director Head of Global Patient Safety Science
Structure Therapeutics
20 days ago
Remote friendly (San Francisco Bay Area)
United States
Medical Affairs
Position Summary:
The Senior Director, Global Patient Safety Science will drive an integrated, proactive, and scientifically rigorous approach to signal detection, aggregate safety assessment, benefit-risk evaluation, and safety governance across development programs.
Responsibilities:
- Provide strategic leadership for safety science across assigned development programs, including safety surveillance, signal detection/assessment, aggregate review, and benefit-risk evaluation.
- Shape safety strategy for products moving from early- to late-phase development.
- Lead cross-functional safety governance (e.g., Signal Management Committees) with robust documentation and escalation.
- Interpret safety data from case reports, aggregate datasets, clinical studies, literature, and external sources.
- Oversee case review processes, Analysis of Similar Events, signal tracking, and escalation pathways (internal stakeholders and CROs/vendors).
- Oversee preparation and quality of core safety deliverables (e.g., DSURs, aggregate reports, Reference Safety Information; safety sections of investigator brochures, protocols, consent forms, clinical study reports, regulatory responses).
- Represent Safety Science on program teams and in interactions with external partners and regulators.
- Partner with Clinical Development and Regulatory Affairs for health authority interactions, inspection readiness, and submission-related safety strategies.
- Build and improve pharmacovigilance processes, governance, SOPs, standards, and tools.
- Lead oversight of CROs and safety service providers.
- Evaluate and implement fit-for-purpose systems/analytics/digital capabilities to strengthen signal detection and reporting.
- Translate safety data into recommendations for senior leadership.
- Mentor colleagues and strengthen functional capability.
Core Competencies / Qualifications:
- Senior safety science lead experience for 1+ clinical programs (signals, aggregate review, benefit-risk assessment, safety input).
- Experience across multiple development stages; ideally early- to late-phase.
- Deep knowledge of global pharmacovigilance regulations, ICH guidelines, signal detection, aggregate reporting, and benefit-risk assessment.
- Strong clinical judgment; ability to interpret and communicate complex safety data to technical and non-technical audiences.
- Track record influencing senior stakeholders; ability to drive alignment without direct authority.
- Experience leading safety governance and representing Safety Science on cross-functional forums.
- Regulatory authority interaction and inspection readiness; NDA/BLA/MAA support preferred.
- Experience overseeing CROs/vendors with strong quality/compliance/deliverable oversight.
- Ability to operate autonomously and prioritize in a fast-paced environment.
- Familiarity with safety databases/analytics (e.g., Argus, Veeva Safety, Spotfire).
- Working knowledge of MedDRA, Standardized MedDRA Queries, Analysis of Similar Events.
- Recognized safety science SME; ability to mentor.
Education/Experience:
- MD, DO, or PharmD (or equivalent).
- Minimum 5 years in drug safety/pharmacovigilance in clinical development; at least 3 years in safety science roles with strategic responsibility.
- Experience in oral small molecules and/or metabolic therapeutic expertise is a plus.
Travel Requirements:
- Periodic travel to company headquarters and external business meetings as needed.
Benefits:
- Anticipated base pay range: $218,000–$378,000.
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity.
- Medical, dental, and vision insurance; 401(k) match; unlimited PTO; paid holidays (including winter shutdown).
Application Instructions:
- Apply via the official career page at BambooHR (BambooHR is the source of truth).
The Senior Director, Global Patient Safety Science will drive an integrated, proactive, and scientifically rigorous approach to signal detection, aggregate safety assessment, benefit-risk evaluation, and safety governance across development programs.
Responsibilities:
- Provide strategic leadership for safety science across assigned development programs, including safety surveillance, signal detection/assessment, aggregate review, and benefit-risk evaluation.
- Shape safety strategy for products moving from early- to late-phase development.
- Lead cross-functional safety governance (e.g., Signal Management Committees) with robust documentation and escalation.
- Interpret safety data from case reports, aggregate datasets, clinical studies, literature, and external sources.
- Oversee case review processes, Analysis of Similar Events, signal tracking, and escalation pathways (internal stakeholders and CROs/vendors).
- Oversee preparation and quality of core safety deliverables (e.g., DSURs, aggregate reports, Reference Safety Information; safety sections of investigator brochures, protocols, consent forms, clinical study reports, regulatory responses).
- Represent Safety Science on program teams and in interactions with external partners and regulators.
- Partner with Clinical Development and Regulatory Affairs for health authority interactions, inspection readiness, and submission-related safety strategies.
- Build and improve pharmacovigilance processes, governance, SOPs, standards, and tools.
- Lead oversight of CROs and safety service providers.
- Evaluate and implement fit-for-purpose systems/analytics/digital capabilities to strengthen signal detection and reporting.
- Translate safety data into recommendations for senior leadership.
- Mentor colleagues and strengthen functional capability.
Core Competencies / Qualifications:
- Senior safety science lead experience for 1+ clinical programs (signals, aggregate review, benefit-risk assessment, safety input).
- Experience across multiple development stages; ideally early- to late-phase.
- Deep knowledge of global pharmacovigilance regulations, ICH guidelines, signal detection, aggregate reporting, and benefit-risk assessment.
- Strong clinical judgment; ability to interpret and communicate complex safety data to technical and non-technical audiences.
- Track record influencing senior stakeholders; ability to drive alignment without direct authority.
- Experience leading safety governance and representing Safety Science on cross-functional forums.
- Regulatory authority interaction and inspection readiness; NDA/BLA/MAA support preferred.
- Experience overseeing CROs/vendors with strong quality/compliance/deliverable oversight.
- Ability to operate autonomously and prioritize in a fast-paced environment.
- Familiarity with safety databases/analytics (e.g., Argus, Veeva Safety, Spotfire).
- Working knowledge of MedDRA, Standardized MedDRA Queries, Analysis of Similar Events.
- Recognized safety science SME; ability to mentor.
Education/Experience:
- MD, DO, or PharmD (or equivalent).
- Minimum 5 years in drug safety/pharmacovigilance in clinical development; at least 3 years in safety science roles with strategic responsibility.
- Experience in oral small molecules and/or metabolic therapeutic expertise is a plus.
Travel Requirements:
- Periodic travel to company headquarters and external business meetings as needed.
Benefits:
- Anticipated base pay range: $218,000–$378,000.
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity.
- Medical, dental, and vision insurance; 401(k) match; unlimited PTO; paid holidays (including winter shutdown).
Application Instructions:
- Apply via the official career page at BambooHR (BambooHR is the source of truth).