Senior Director, Quality Policy & Advocacy

Gilead Sciences•Washington, DC

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. The Senior Director, Quality Policy and Advocacy is a recognized expert both inside and outside the business and is responsible for leading various global aspects of internal and external-facing advocacy as applicable to support the Gilead portfolio. This leader will represent the business externally and will be focused on influencing while developing and advocating policy positions (internally and externally) for Quality Policy issues in conjunction with the Gilead CMC Regulatory Policy Office. The role will be focused primarily on the North American policy landscape, with appropriate alignment and involvement in the global policy landscape and will be responsible for positioning Gilead’s products/ portfolio for regulatory and technical success, contemporizing processes as needed, and supporting the holistic global harmonization of marketing applications. They will be accountable for consulting with project teams on the implementation of global requirements (e.g., ICH) and other appropriate technical regulations and guidelines. This position will require a strong and extensive external network as well as excellent communication and collaboration skills, as well as the ability to quickly digest, understand and communicate complex regulatory issues to a variety of stakeholders. The team member will also be responsible for interacting with multiple internal and external stakeholders to ensure that dossiers as written meet Health Authority guidance and have clear messaging. The role will report directly to the Global Head of Quality Policy and Advocacy

Requirements

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.

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.

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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