Director, Clinical Development (MD) at Gilead in Foster City, CA

Job description

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 In this role, you will lead or contribute to multiple aspects of clinical development programs within the Virology Therapeutic Area. Working as part of a cross-functional team, you will typically lead one or more components of Virology Clinical Development programs, including those in Respiratory/Emerging Viruses. For the assigned projects, you are accountable for 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, clinical development inputs into regulatory documentation, publications, and scientific presentations, pandemic preparedness, and outbreak responses to emerging viruses. KEY RESPONSIBILITIES: Provides scientific and clinical expertise to cross-functional teams to support clinical development project deliverables and timelines, including but not limited to Respiratory/Emerging Viruses as well as pandemic preparedness and/or emerging outbreak responses. 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. Basic Qualifications: MD and Four Years' Experience Preferred Qualifications: Clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment; Experience in the biopharma industry is preferred, with clinical experience in medical monitoring. Training and/or experience in Infectious Diseases, Immunology, Pulmonology, or a related medical specialty, and familiarity with emerging viruses and/or pandemic preparedness.is preferred. Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia. Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations. Experience presenting scientific or clinical data thro