Sr Director, Clinical Development (MD)

Role Summary

Sr Director, Clinical Development (MD) is a senior physician leader responsible for directing clinical development across the Respiratory and Emerging Viruses portfolio. You will lead trial design and execution, medical monitoring, and regulatory communications, working with cross-functional teams and senior leadership. The role requires MD-level qualifications with substantial drug development experience and the ability to operate globally.

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.

Qualifications

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

Skills

• 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.
• Strong leadership skills with the ability to set vision, lead change, and mentor others.
• Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
• 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.

Additional Requirements

• Travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings.