Head of CMC Regulatory Affairs – Small Molecules

Gilead Sciences•Foster City, CA

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.

Requirements

A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.).
Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions.
Application of sound and accurate judgment to make timely decisions.
Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
Demonstrated organizational leadership skills at both functional and enterprise levels.
Excellent strategic acumen, collaboration, and communication skills are required.

Responsibilities

Lead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives.
Lead global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions.
Develop global CMC regulatory strategies to enable life-cycle product/process development strategy while maintaining global licensure and right to operate of Gilead’s operations.
Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
Lead the integration and implementation of CMC Team Leaders and CMC Strategies (Regulatory Scientists).
Lead development of regulatory strategies and solutions for complex CMC challenges for Clinical through Growth (newly approved) products submission, commercial registration, including risk mitigation.
Exercise expertise in the interpretation and implementation of ICH guidelines with a goal of an approved/ harmonized regulatory control strategy.
Ensure regulatory conformance & consistency for assigned products globally in compliance with regulatory requirements and internal procedures.
Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead for support with opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.
Develop meaningful and collaborative relationships with local & global internal/ external partners.
Lead CMC strategies, assess risks, and develop contingency plans, including major, complex applications.
Demonstrate and model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities; Embrace and comply with global CMC principles of integrity.
Demonstrate success in influencing without positional authority within a highly matrixed organization.
Drive the continuous improvement and cultural evolution of the Small Molecules organization while promoting development of talent at all levels.