Director/Senior Director, Head of Global Patient Safety Science

Structure Therapeutics•South San Francisco, CA

3d•Hybrid

About The Position

Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. Position Summary: The Senior Director, Global Patient Safety Science is designed for a highly experienced safety leader who can operate with broad autonomy, influence senior cross-functional stakeholders, and drive an integrated, proactive, and scientifically rigorous approach to signal detection, aggregate safety assessment, benefit-risk evaluation, and safety governance across development programs. The Senior Director will be a key safety partner to Clinical Development, Regulatory Affairs, Medical Affairs, Biometrics, and external partners, ensuring that safety considerations are embedded in development strategy, regulatory interactions, and cross-functional decision-making.

Requirements

Demonstrated experience serving as the senior safety science lead for one or more clinical programs, with accountability for signal detection, aggregate review, benefit-risk assessment, and safety input into development strategy.
Strong experience supporting products across multiple stages of development, ideally including assets transitioning from early- to late-phase clinical development.
Deep knowledge of global pharmacovigilance regulations, ICH guidelines, signal detection practices, aggregate reporting requirements, and benefit-risk assessment.
Strong clinical judgment and a demonstrated ability to interpret, synthesize, and communicate complex safety and clinical data to both technical and non-technical audiences.
Track record of influencing cross-functional and senior stakeholders on complex safety issues, including the ability to drive alignment and decision-making without direct authority.
Experience leading or chairing safety governance activities and representing Safety Science on program teams and other cross-functional forums.
Experience with regulatory authority interactions, inspection readiness, and major submission support activities; direct experience supporting NDA, BLA, or MAA activities is strongly preferred.
Experience overseeing CROs, vendors, and external partners, with strong command of quality, compliance, deliverable oversight, and issue escalation.
Demonstrated ability to operate with broad autonomy, prioritize across competing demands, and bring strategic perspective in a fast-paced, evolving biotech environment.
Familiarity with safety databases and analytics platforms such as Argus, Veeva Safety, Spotfire, or related tools.
Working knowledge of MedDRA, Standardized MedDRA Queries, Analysis of Similar Events, and other core pharmacovigilance methodologies.
Recognized subject matter expertise in safety science, with the credibility to mentor colleagues, shape functional standards, and represent the function internally and externally as appropriate.
MD, DO, or PharmD, or equivalent.
Minimum of 5 years of experience in drug safety/pharmacovigilance within clinical development, including at least 3 years in safety science roles with strategic responsibility for clinical-stage assets.

Nice To Haves

Experience in oral small molecules, and/or metabolic therapeutic expertise is a plus.

Responsibilities

Provide strategic leadership for safety science across assigned development programs, with accountability for integrated safety surveillance, signal detection, signal assessment, aggregate review, and benefit-risk evaluation.
Shape the safety strategy for products advancing from early- to late-phase clinical development, ensuring alignment with program objectives, regulatory expectations, and long-term portfolio needs.
Lead cross-functional safety governance, including Signal Management Committees and other safety review/governance forums, ensuring robust decision-making, clear documentation, and effective escalation of key risks.
Drive high-quality interpretation of safety data from multiple sources, including individual case reports, aggregate datasets, clinical studies, literature, and external data sources.
Provide senior oversight and scientific direction for individual case review processes, Analysis of Similar Events, signal tracking, and escalation pathways, partnering closely with internal stakeholders and external vendors.
Oversee the preparation and strategic quality of core safety deliverables, including DSURs and other aggregate reports, Reference Safety Information, safety sections of Investigator Brochures, protocols, informed consent forms, clinical study reports, regulatory responses, and other key documents.
Represent Safety Science on cross-functional program teams and in interactions with external partners and regulatory authorities, ensuring safety perspectives are clearly articulated and incorporated into development plans.
Partner with Clinical Development and Regulatory leaders to support health authority interactions, inspection readiness activities, and submission-related safety strategies, including support for future NDA, BLA, or other major regulatory milestones.
Build and continuously improve pharmacovigilance processes, governance, SOPs, standards, and tools to enable scalability, inspection readiness, and operational excellence.
Act as a senior technical leader and trusted advisor within Safety and across the broader organization, raising the bar for scientific rigor, decision quality, and cross-functional alignment.
Lead oversight of CROs and safety service providers, establishing clear expectations, monitoring performance, and ensuring delivery against quality, compliance, and timeline commitments.
Evaluate and implement fit-for-purpose systems, analytics, and digital capabilities that strengthen signal detection, reporting, data visibility, and organizational scalability.
Influence portfolio- and function-level decisions by translating complex safety data into clear recommendations for senior leadership and cross-functional stakeholders.
Identify emerging risks, dependencies, and resource needs across programs, and proactively drive mitigation plans that protect patients, studies, timelines, and company objectives.
Serve as a recognized internal expert in clinical safety science and contribute externally, as appropriate, through regulatory engagement, scientific exchange, and thought leadership in the field.
Mentor colleagues, share expertise generously, and help strengthen functional capability across the organization without formal people management responsibility.