Sr Director, Clinical Development (MD)

Gilead Sciences • Foster City, CA

8d

About The Position

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 Essential Duties and Job Functions 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.

Requirements

• 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.
• 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.

Nice To Haves

• Experience in Infectious Diseases or Respiratory is preferred but not required.

Responsibilities

• 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.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree