Exec Director, Regulatory RWE Strategy and Innovation

Scorpion Therapeutics; California (MO); On-site; USD 180,000 - 280,000; Full time

Job summary

Gilead is seeking an Executive Director of Regulatory Real-World Evidence (RWE) Strategy and Innovation within Clinical Data Sciences, based in Foster City, CA. The role leads enterprise-level strategy to optimize RWE for regulatory decision-making, shaping policies and standards while fostering external partnerships.

Responsibilities include supporting health authority interactions, advancing innovative study designs and analytics, and building compliant infrastructure for high-quality RWE

Qualifications

• PhD, MD, PharmD, DrPH or ScD with 12+ years (PhD) or 14+ years (MS/MPH) of relevant experience.
• Proven leadership in observational research supporting regulatory filings.
• Expertise in global RWE landscape, data sources, and advanced study methodologies.
• Experience with regulatory interactions and policy shaping.

Responsibilities

• shape policies, interpret evolving regulatory landscapes, develop standards, and foster external partnerships;
• support health authority interactions;
• advance innovative study designs and analytical methods;
• build infrastructure for high-quality, compliant RWE generation.

Job description

Role

Executive Director of Regulatory RWE Strategy and Innovation within Gilead's Clinical Data Sciences, leading enterprise-level strategy to optimize Real-World Evidence (RWE) use in regulatory decision-making.

Responsibilities

• shape policies, interpret evolving regulatory landscapes, develop standards, and foster external partnerships;
• support health authority interactions;
• advance innovative study designs and analytical methods;
• build infrastructure for high-quality, compliant RWE generation.

Requirements

• PhD, MD, PharmD, DrPH, or ScD with 12+ years (PhD) or 14+ years (MS/MPH) of relevant experience;
• proven leadership in observational research supporting regulatory filings;
• expertise in global RWE landscape, data sources, and advanced study methodologies;
• experience with regulatory interactions and policy shaping.

Preferred

regulatory agency experience, involvement with innovative methods like Bayesian and AI/ML, contributions to health policy, and experience across therapeutic areas/modalities.

HighValue

focus on regulatory-grade RWE, global health authority engagement, innovative observational and hybrid study designs, and external partnership management.

Location

Foster City, CA, onsite with 10-15% travel to domestic and international sites.