About Gilead Sciences

Gilead Sciences is a biopharmaceutical leader dedicated to creating a healthier world for all. For over 35 years, Gilead has pioneered therapies for HIV, viral hepatitis, COVID-19, cancer, and inflammatory diseases. Headquartered in Foster City, California, the company drives relentless innovation to improve lives and ensure global access to transformative medicines. With a mission rooted in collaboration and determination, Gilead's teams advance bold scientific ambitions in oncology, virology, and beyond.

Role Overview

The Head of CMC Regulatory Affairs – Strategy and Operations role at Gilead Sciences in Foster City, California, is a senior leadership position shaping the future of Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA). This strategic leader will build capabilities, drive operational excellence, and spearhead digital transformation. Reporting into executive leadership, you will centralize key activities, foster cross-functional partnerships, and align CMC RA with Gilead's global pipeline ambitions in HIV treatments, oncology breakthroughs, and inflammatory disease solutions.

Strategic Impact

In this role, you will own the CMC RA operating model, roadmap, and continuous improvement initiatives. By blending regulatory expertise with business acumen, you will position Gilead at the forefront of biopharmaceutical regulatory strategy.

Key Responsibilities

Lead with vision and execution across three core pillars: Strategy & Capability Building, Operations & Cross-Functional Leadership, and Digital Enablement.

• Develop an innovation roadmap guiding CMC RA resource and budget investments.
• Design, build, and lead a high-performing organization centralizing processes, systems, data, and tools.
• Define and track Key Performance Indicators (KPIs) for CMC RA performance.
• Collaborate with Regulatory Affairs, Quality, Technical Development, and Manufacturing to modernize processes and digital strategies.
• Manage centralized resource forecasting via Planisware and drive operational excellence to identify synergies and reduce spending.
• Oversee digital modernization of platforms like Regulatory Information Management (RIM) and integrate AI fluency programs.
• Lead knowledge management guidelines, workforce upskilling, and training strategies aligned with enterprise initiatives.

Qualifications & Requirements

Gilead seeks a proven leader with deep domain expertise and transformative capabilities.

• PhD or MS with 14+ years of relevant experience, or BS with 16+ years; degree in chemistry or related scientific discipline strongly preferred.
• Extensive experience in regulatory operations, strategic planning, and CMC RA execution across drug development modalities.
• Comprehensive knowledge of biopharmaceutical R&D, commercialization, and regulatory frameworks.
• Proven track record designing and implementing digital tools (RIM, structured content authoring, LIMS, GenAI) with enterprise integration.
• Strategic thinking, influence in matrixed environments, and excellence in communication and change leadership.
• Strong business acumen, data governance, and ability to optimize organizations.

Benefits & Perks

Gilead offers a premium compensation package and comprehensive benefits tailored for top talent.

• Highly competitive salary range: $302,005 - $390,830 USD annually.
• Robust health, dental, and vision insurance with wellness programs.
• 401(k) matching, stock options, and performance bonuses.
• Generous PTO, parental leave, and flexible work arrangements.
• Professional development funding, leadership training, and tuition reimbursement.
• On-site fitness centers, childcare support, and employee resource groups fostering inclusion.

Career Growth

At Gilead, people leaders are pivotal to culture evolution. This role offers unparalleled growth, mentoring high-potential teams and influencing enterprise-wide strategies. Advance your career impacting HIV therapies, oncology innovations, and inflammatory disease treatments while building expertise in digital transformation and AI in biopharma.

Why Join Gilead

Join a company where every role drives life-changing impact. Gilead's commitment to bold ambitions in HIV, oncology, and inflammatory diseases means your work advances global health. In Foster City, collaborate with world-class scientists in a supportive, inclusive environment. Be part of a team relentlessly fighting health challenges, with resources to innovate and thrive.

Role FAQs

Q: What experience is required?
A: PhD/MS with 14+ years or BS with 16+ years in CMC RA, plus digital and leadership expertise.

Q: Is relocation support available?
A: Gilead provides competitive relocation packages for qualified candidates.

Q: What modalities does this role cover?
A: Experience across small molecules, biologics, and other product types in Gilead's pipeline.

Q: How does this role contribute to Gilead's mission?
A: By streamlining CMC RA, you enable faster delivery of therapies for HIV, cancer, and inflammatory diseases.

Q: What is the reporting structure?
A: Direct leadership over CMC RA operations, partnering with executive stakeholders.