Exec Director, Global Regulatory Strategy Head of Inflammation

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

Key Responsibilities

• Provide leadership to the global inflammation regulatory organization to advance Gileads portfolio across the full product lifecycle from Phase I through Phase IV in alignment with corporate objectives.

• Leverage in-depth regulatory knowledge and inflammation expertise to deliver strategic and technical guidance including innovative and precedentinformed regulatory approaches to global registration.

• Dissect and distill complex regulatory issues to provide clear strategic direction and support interactions with health authorities including preparation of highquality regulatory content.

• Hire develop and retain diverse top talent; set clear and aspirational goals; and coach direct reports on performance development and career progression.

• Foster a culture of excellence and innovation empowering teams to perform at their highest potential.

• Own and manage departmental budget and resource planning.

• Build maintain and strengthen partnerships across Development PDM and Commercial functions to support nearterm regulatory execution and longterm strategic vision.

• Represent GRA at Development Review Committees (DRCs) and provide impactful regulatory leadership to support robust development plans.

• Provide regulatory oversight and guidance for due diligences related to inlicensing external collaborations and acquisitions.

• Contribute as a member of the Global Regulatory Affairs Leadership Team to regulatory vision roadmaps initiatives and outcomes.

• Ensure all activities are conducted in full compliance with applicable laws regulations ICH guidelines regional requirements and internal policies and SOPs.

• Maintain strong awareness of the external regulatory landscape and evolving requirements impacting Gileads portfolio.

• Develop and champion highimpact initiatives that advance the regulatory function and enterprise goals.

Qualifications

• Advanced science degree (PhD PharmD MD or MSc) with 14 years or Science Degree (BSc) with 16 years of experience and regulatory leadership experience including leadership of global teams.

• Deep expertise in the inflammation therapeutic area ideally gained through regulatory leadership of multiple global development programs and lifecycle management activities including NDA/MAA submissions.

• Proven ability to represent the company in complex negotiations with regulatory authorities in the US EU Japan China and other regions.

• Strong influence interpersonal and communication skills with the ability to collaborate effectively across functions.

• Extensive knowledge of global regulatory requirements including ICH and regional frameworks and the ability to assess their impact on business strategy.

• Demonstrated capability to lead transformational initiatives in response to evolving legislation and regulatory expectations.

• Ability to critically review complex scientific and technical documents and influence decisionmaking across matrixed organizations.

• Strong executive presence with the ability to navigate seniorlevel stakeholder environments effectively.

• Recognized internally and externally as an expert regulatory resource.

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Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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