
Sr Director, Clinical Development (MD)
Gilead Sciences, Inc., Foster City, California, United States, 94420
* Lead execution of clinical trials and collaborations across the Respiratory and Emerging Viruses portfolio, working closely with senior leadership of the Respiratory and Emerging Viruses team.* Ensure adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.* Coordinate the collection and analysis of clinical data for internal analysis and review.* Serve as a key member of the team responsible for all scientific aspects of conceptualizing, planning, and executing trials.* Lead or direct clinical trial protocol design and clinical study reporting for assigned molecules and products.* Provide or oversee ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.* Oversee other Development Leads across the assigned project portfolio, as applicable.* Serve as the lead for written and oral communications with health authorities.* Lead, oversee, and direct the clinical development components of regulatory documents, investigator brochures, and development plans.* Coordinate the collection and assimilation of data for internal analysis and review, and support preparation or review of data listings, summary tables, study results, and scientific presentations.* Present scientific information at scientific conferences and clinical study investigator meetings; when applicable, take the lead in authoring scientific publications.* Assist in the evaluation of business development opportunities.* Adhere to regulatory requirements of study conduct, industry standards of Good Clinical Practice, and Gilead SOPs.* Serve as a scientific and clinical resource within Gilead Clinical Research.* Provide scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management teams.* MD or equivalent with 8+ years of experience in drug development in industry, academia, or a related environment, working within cross‑functional project or program teams with proven success.* Relevant experience in clinical research with a basic understanding of Good Clinical Practice.* Experience in Infectious Diseases or Respiratory is preferred but not required.* Ability to think analytically and strategically to formulate, develop, and execute clinical plans.* Strong leadership skills with the ability to set vision, lead change, and mentor others.* Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue, fostering robust idea-sharing and creative problem solving.* Excellent scientific written and oral communication skills.* Ability to engage internal and external experts in constructive scientific and clinical dialogue regarding study design, study conduct, and interpretation of clinical results.* Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings.
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