Gilead Sciences · 2 weeks ago
Senior Director, Quality Policy & Advocacy
Washington, DC
Full-time
Onsite
Director/Executive
$221K/yr - $286K/yr
12+ years expGilead Sciences is focused on creating a healthier world by tackling major health challenges. The Senior Director, Quality Policy and Advocacy will lead global advocacy efforts, develop policy positions, and ensure regulatory success for Gilead’s portfolio in the North American landscape.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Serve as critical and recognized, internally and externally, thought leader and contributor to the Quality Policy & Advocacy Office at Gilead Sciences
Lead, coordinate, and (as needed) represent the business in ICH, trade associations (e.g., PhRMA), global technical associations (e.g., ISPE, PDA, DIA) with minimal oversight
Lead development of Gilead’s global Quality policies and priorities, with a focus on North American facing assets
Develop, advise global senior leadership, and implement solutions to address regulatory complexities and challenges across regions, using creative and innovative approaches as needed
Present and articulate complex global Quality issues for resolution, communicating regularly with key global stakeholders to ensure alignment, provide consultation as a scientific/technical resource within the department/cross-functional and therapeutic teams for assigned projects, mentor and share experience with colleagues
Facilitate and support global project teams’ identification of solutions for precedent-setting project issues and enable their understanding of local (North American-facing) regulations and requirements
Contribute to the strategic direction of broad global harmonization efforts and enable new technologies – with the focus of benefiting Gilead’s scientists
Build/maintain trust and establish a strong and effective network with relevant external partners, including global regulatory authorities, nonprofit organizations, and academic institutions, with specific focus on European health authorities and cross-industry associations
Matrix/coordinate/lead strategy development with CMC Regulatory Affairs Policy Advisory and Intelligence Office
Develop and implement external strategies for Gilead’s critical and precedent-setting initiatives (new technology, complex projects)
Serve as the policy point of contact for select partners and stakeholders and communicate timely and relevant information/knowledge sharing
Independently lead key global implementation efforts and highly significant projects to ensure Gilead’s participation in multiple external forums addressing the development of global regulatory guidance
Qualification
Required
A scientific degree with directly relevant professional experience in global Quality and related technical areas of at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, PharmD, or MD
Demonstrated track record in impacting global Quality, developing Quality and regulatory strategies, and leadership in multiple international regulatory/industry forums for topics of external policy relevance
Expert on global guidelines and regulations, with a focus on those that are North American facing (e.g., PhRMA)
Strong knowledge of ICH guideline interpretation and implementation, previous ICH experience is highly preferred
Demonstrated organizational leadership skills at the functional level
Excellent strategic acumen, collaboration, and communication skills are required
Preferred
Strong knowledge of ICH guideline interpretation and implementation, previous ICH experience is highly preferred
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-16
FierceBiotech
2026-01-16
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