Senior Director, Global Regulatory Affairs Liaison, Pediatric Center of Excellence

About Gilead Sciences

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.

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Role Overview: Senior Director, Global Regulatory Affairs Liaison, Pediatric Center of Excellence

Global Therapeutic Area (TA) Regulatory Liaisons is a core function within Gilead's Global Regulatory Affairs (GRA) organization and acts as a critical strategic partner across drug discovery, development and commercial teams. Global TA Regulatory Liaisons develop regulatory strategic options and work closely with cross-functional leaders and regulatory authorities to determine appropriate pathways to obtain and maintain licensure and optimal formulary listings. These strategies are essential in obtaining and maintaining licensure of Gilead's medicinal products and proprietary methodologies and technologies by managing registrations, other filings and regulatory agency communications and interactions in our key markets around the world.

Gilead's Pediatric Center of Excellence is a global hub in Dublin, Ireland, dedicated to advancing research and development of treatments for children with serious diseases, including HIV, viral hepatitis, COVID-19, and cancer. As the Senior Director, Global Regulatory Affairs Liaison, Pediatric Center of Excellence, you will act as the Franchise Lead for Regulatory Affairs at this center. You will provide leadership and mentorship for your direct reports by overseeing and guiding the development and execution of regulatory strategies, plans and objectives for pediatric development of products and compounds across the Virology, Oncology and Inflammation therapeutic areas in alignment with and within the overall global development of a product. This may include overseeing the development of global pediatric regulatory plans and preparation of pediatric regulatory submissions, monitoring the progress and completion of global pediatric commitments, and guiding and advising colleagues in the thorough and compliant completion of these activities. You may act as the Global Regulatory Lead and/or serve as a Gilead contact for regulatory authorities as needed.

You will act as a senior regulatory representative and pediatric subject matter expert to cross-functional leaders and teams. You will play a leadership role on regulatory leadership teams, at the Pediatric Center of Excellence and in ad hoc or special projects/initiatives that seek to continuously improve or advance GRA capabilities.

Key Responsibilities

• Accountable for oversight and leadership of the development and successful completion of global pediatric regulatory strategies, submissions, documents, activities, and other deliverables for products across the Virology, Oncology and Inflammation TAs to achieve strategic milestones and objectives.
• Makes significant contributions to the ongoing development and optimization of pediatric regulatory strategies, processes, standards, and practices in collaboration across Global TA regulatory liaisons and cross-functional teams to ensure alignment with broader product development goals, driving efficiency and enhancing organizational capabilities.
• Represents Gilead in negotiations with regulatory authorities as needed.
• Proactively identifies regulatory or pediatric-related risks/issues and ensures timely development of mitigation and/or contingency plans.
• Manages one or more direct reports.
• Provides accurate and thorough input and recommendations into resource plans required to complete deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
• Provides significant leadership as a member of the Global TA Regulatory Liaison leadership team and leads or contributes to non-program-related corporate/department initiatives, process improvements, best practices, and projects.
• Provides leadership and advisement for Pediatric Center of Excellence site management.

Required Qualifications & Skills

Education & Experience

• MA/MS/MBA/PharmD/PhD with 12+ years’ relevant experience, or BA/BS with 14+ years’ relevant experience.
• Extensive experience in Global Regulatory Affairs (pharmaceutical industry experience is strongly preferred) and developing global pediatric regulatory strategies.
• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
• Extensive leadership experience and proven effectiveness through direct people leadership or matrix leadership.
• Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.
• Experience and proven effectiveness negotiating with regulatory authorities.
• Extensive experience leading and influencing cross-functional teams and activities across a broad spectrum of programs, projects and other activities.
• Proven track record of successfully managing large scale, complex, time-sensitive projects.

Knowledge & Skills

• Exceptional interpersonal, self-awareness and negotiation skills, including effective verbal/written communication, team orientation, critical thinking, active listening, problem-solving, dependability, and adaptability, and understanding of team dynamics.
• Expert knowledge of the drug development process, and global and regional regulatory requirements for medicinal products.
• Advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, and understanding and effectively advising on its regulatory implications.
• Demonstrable ability to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
• Ability to summarize complex matters into a clear business case and roadmap for execution.
• Strong coaching capabilities to mentor/develop staff.
• Ability to travel when needed.
• This role requires the successful candidate to work at our Dublin office – therefore candidates that are not based within a commutable distance to the office must be open to relocation.

Key Skills/Competency

• Global Regulatory Affairs
• Pediatric Drug Development
• Regulatory Strategy
• Cross-functional Leadership
• Regulatory Submissions
• Negotiation with Authorities
• Risk Mitigation
• People Management
• Pharmaceutical Industry
• Therapeutic Area Expertise (Virology, Oncology, Inflammation)