Gilead Sciences, Inc. is hiring a Sr. Director, Clinical Development (MD)- Inflammation/Fibrosis Therapeutic Area

Gilead Sciences is hiring a Sr. Director, Clinical Development (MD) to provide scientific and clinical leadership for our Inflammation/Fibrosis therapeutic area. In this role, you will lead clinical development efforts for primary biliary cholangitis (PBC) with future potential for other indications, generating clinical development plans, overseeing studies, and contributing to regulatory strategy.

What You'll Do

• Lead or oversee clinical trial protocol design, analysis planning, clinical study report development, and responses to health authority inquiries.
• Provide scientific and clinical leadership or oversight in preparing, reviewing, and interpreting clinical study data to ensure high quality.
• Oversee or perform clinical study medical monitoring, including assessing eligibility criteria, addressing investigator questions, safety monitoring, and data review.
• Lead the development of the target product profile and clinical development plan for assigned molecules/products.
• Contribute to global regulatory filing strategy and lead clinical development contributions in preparing and reviewing regulatory documents.
• Provide scientific and clinical leadership or oversight in preparing investigator brochures.
• Provide scientific and clinical leadership to cross-functional teams including real world evidence and health economics and outcomes efforts.
• Present data at scientific conferences, clinical study investigator meetings, or to regulatory authorities.
• Adhere to regulatory requirements of study conduct, industry standards of Good Clinical Practice, and Gilead SOPs.

What We're Looking For

• MD or equivalent.
• 6+ years of clinical, scientific, and/or drug development experience in the biopharma industry, academia, or a related environment.

Nice to Have

• Board certification in hepatology or gastroenterology.
• Other backgrounds considered: pulmonology, rheumatology, or other internal medicine background with experience in clinical research in chronic liver diseases, inflammation/fibrosis, autoimmunity and/or PBC/MASH.
• Experience in the biopharma industry with medical monitoring and addressing medical concerns during clinical studies.
• Experience leading study concept and protocol design.
• Track-record of leading cross-functional projects or teams.
• Experience with regulatory filings, clinical publications, and scientific presentations.
• Demonstrated excellence in a fast-paced environment, effectively managing multiple clinical project deliverables and priorities.
• Strong scientific acumen as shown through a past research track record.
• Core expertise in the assigned or related disease areas, or a strong desire to develop the necessary expertise.
• Track record of independently leading clinical development deliverables for one or more projects.
• Thorough understanding of pharmaceutical regulatory requirements and their impact on study development and execution.
• Strong oral and written communication skills.
• Organized and self-motivated.
• Collaborative work style with strong interpersonal skills.
• Strong desire to develop new expertise and learn new areas to accomplish team goals and advance professional development.
• Ability to travel when needed.

Team & Environment

You will work within a matrixed environment.

Benefits & Compensation

• Compensation range: $302,005.00 - $390,830.00.
• Company-sponsored medical, dental, vision, and life insurance plans.
• Paid time off.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives (eligibility may vary).

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences.