Director, Clinical Development (MD)

Gilead SciencesUnited States - California - Foster Cityonsite$261k–$338kView the original posting at Gilead Sciences ↗

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 At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Director, Clinical Development (MD) , at Gilead You will typically lead multiple components of clinical trial programs in Inflammation/Fibrosis clinical development, including primary biliary cholangitis (PBC), and/or metabolic dysfunction-associated steatohepatitis (MASH). You may also act as the Physician Responsible on certain projects. For the assigned projects, you are accountable or various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations. This work will include the synthesis of data from Phase 3 and other studies, supporting activities linked to global registration of a late-stage therapeutic in clinical development, including assisting in the execution of clinical postmarketing requirements, and other clinical development-related commitments. This position is based at Gilead's global headquarters in Foster City, California, with a hybrid work model that includes optional work-from-home days on Mondays and Fridays. Clinical Development Strategy & Program Leadership Contribute to or lead development of Target Product Profiles (TPPs) and Clinical Development Plans for assigned molecules and products. Provide scientific and clinical leadership to cross-functional teams to support development objectives, project milestones, and timelines. Support clinical strategy decisions through interpretation of emerging clinical and scientific data. Clinical Trial Design & Execution Lead or contribute to clinical trial protocol design and development. Provide ongoing medical monitoring for clinical studies, including eligibility review, safety assessment, toxicity management, and drug safety surveillance activities. Support study conduct in accordance with regulatory requirements, Good Clinical Practice (GCP), and company procedures. Regulatory & Scientific Contributions Contribute to the preparation and review of regulatory submissions, investigator brochures, health authority responses, and development documentation. Support development of clinical study reports and other study-related deliverables. Provide clinical d

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