Director, CMC Portfolio Operations and Insights

Responsibilities

• Lead and set the strategy for a CMC RA portfolio operations capability, driving enterprise-level visibility and proactive risk management.
• Own the end-to-end portfolio visibility and insights strategy across the CMC regulatory pipeline.
• Translate complex multi-program dependencies into executive-level insights to enable prioritization and resource allocation.
• Develop consolidated operational views of regulatory deliverables to support long-range planning and capacity management.
• Identify systemic process gaps and implement improvement roadmaps to enhance operational excellence.
• Drive the adoption of digital tools, analytics, and enabling technologies to modernize CMC regulatory operations.
• Establish performance metrics and dashboards to provide real-time insight into portfolio health and submission readiness.
• Provide strategic leadership and mentorship to team members and matrixed cross-functional partners.

Requirements

• 12+ years of experience with a BA/BS in Life Sciences, Engineering, or a related field; 10+ years with an MA/MS/MBA; or 8+ years with a PharmD/PhD.
• Extensive experience in CMC, Regulatory Affairs, or related functions within the biopharma industry.
• Demonstrated experience owning strategy and execution for complex portfolios or regulatory operations at scale.
• Deep understanding of CMC regulatory requirements across global health authorities (FDA, EMA, ICH).
• Proven ability to drive process improvement and operational change at a functional or enterprise level.
• Exceptional communication and stakeholder management skills with the ability to influence senior leadership.

Preferred Qualifications

• Experience in digital transformation, operational excellence, or non-product initiatives.
• Proficiency with Veeva infrastructure (Vault RIM).
• PMP certification.
• Experience with vendor management.

About the Company

Gilead is a biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years. We work relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.