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.
Job Description
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. You will act as the Franchise Lead for Regulatory Affairs at the Pediatric Center of Excellence. 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 the serve as a Gilead contact to / for regulatory authorities as needed.
As Senior Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence, 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.
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.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients.
Please see the following for the qualifications and skills we seek for this role:
Education & Experience
MA/MS/MBA/PharmD/PhD with 12+ years’ relevant experience.
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.
When needed, ability to travel.
This role requires the successful candidate to work at our Dublin office – We will consider suitably qualified candidates from other countries who express an interest with an understanding that relocation to Dublin would be required and supported by Gilead.
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
Please apply via the Internal Career Opportunities portal in Workday.
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