Assoc Clinical Development Director (MD)

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.

We are seeking a highly motivated Associate Director- Clinical Development (MD) to be based in Foster City. In this role, you will contribute to multiple aspects of clinical development programs in virology, with a focus on hepatitis. Working as part of a cross-functional team, you will support the planning, execution, monitoring, and interpretation of clinical studies. For assigned projects, you will contribute to a range of clinical trial activities, including study protocol development, investigator and study-related documentation, medical monitoring activities, data review and interpretation, study reporting, regulatory submissions, scientific publications, and presentations. This role provides an opportunity to gain broad experience across the clinical development process while helping advance innovative therapies for patients with viral diseases.

Provides scientific and clinical expertise to cross-functional teams to support clinical development project deliverables and timelines. Contributes to the development and review of clinical trial protocols, clinical study reports, and responses to health authority inquiries. Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance. Contributes to the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures, and development plans. Supports the collection, review, and interpretation of clinical data for internal analysis and decision-making. Manages the preparation and/or review of data listings, summary tables, study results and scientific presentations. Presents scientific and clinical information at investigator meetings, internal forums, and scientific conferences. Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

MD/DO or equivalent Preferred qualifications: Training and/or experience in Hepatology (including in hepatitis B and/or D), Infectious Diseases, Immunology, or a related medical specialty is preferred. Exposure to clinical research through academic, fellowship, investigator-initiated, translational, or industry-sponsored studies is preferred. Interest in clinical drug development and clinical trial design, with a demonstrated desire to build expertise in these areas. Experience presenting scientific or clinical data through publications, abstracts, posters, presentations, or other scholarly activities is preferred. Experience collaborating across multidisciplinary teams in academic, clinical, research, or industry settings is preferred. Additional Qualifications: Demonstrated ability to learn quickly and apply new concepts in a