Exec Director, Clinical Development (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 leader to join us as Executive Director, Clinical Development (MD) in the multiple myeloma disease area. This role will play a key role in development and oversight of cell therapy programs, collaboration with external partners, and support evaluation opportunities for expanding the clinical development program. You will lead a portfolio of clinical trial programs in cell therapy clinical development: Accountable for the design, conduct, evaluation, close-out and reporting of clinical trials across the portfolio. Lead and direct the development, implementation, and execution of the clinical development strategy, which will include development of the Target Product Profile and Clinical Development Plan. Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications, and scientific presentations.

Leads or otherwise oversees and directs the development of the Target Product Profile and Clinical Development Plan for assigned molecules/products. Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules / products. Routinely represents the assigned products in cross-functional steering and/or governance committees. Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules/products. Leads both written and oral communications with health authorities. Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance. Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans. Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations. Presents scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on authoring scientific publications. May assist in the clinical evaluation of business development opportunities. Develops thought leader and other external relationships that can guide short and long-range clinical development strategies and direction for the disease or therapeutic area overall. Adheres to regulatory requirements inclusive of GCP and ICH guidelines of study conduct, and industry practices and