Director, Clinical Development (MD)

Gilead Sciences • Foster City, CA

6d

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.

Requirements

• MD or equivalent with 4+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• Board certification in hepatology, gastroenterology is preferred; however, other inflammatory backgrounds including pulmonology, rheumatology, immunology with experience performing clinical research studies in those with chronic liver diseases, inflammation/fibrosis, autoimmunity and/or PBC/MASH also considered.
• Experience in the biopharma industry is preferred, with clinical experience in medical monitoring and familiarity addressing medical concerns.
• 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.
• Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
• Proven analytical abilities as demonstrated through past experience and/or academic research.
• Core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
• Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
• Strong communication and organizational skills.
• Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
• When needed, ability to travel.

Nice To Haves

• Board certification in hepatology, gastroenterology is preferred
• Experience in the biopharma industry is preferred

Responsibilities

• Lead multiple components of clinical trial programs in Inflammation/Fibrosis clinical development, including primary biliary cholangitis (PBC), and/or metabolic dysfunction-associated steatohepatitis (MASH).
• Act as the Physician Responsible on certain projects.
• Accountable for various aspects of ongoing clinical trial program-related activities, including study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.
• Synthesize data from Phase 3 and other studies, supporting activities linked to global registration of a late-stage therapeutic in clinical development, including assisting in the execution of clinical postmarketing requirements, and other clinical development-related commitments.
• Provide input into or lead the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
• Provide scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
• Provide input into, or otherwise lead, clinical trial protocol design, clinical study reports and health authority inquiries.
• Provide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Manage the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
• Coordinate the collection and assimilation of ongoing data for internal analysis and review.
• Coordinate and manage the preparation and/or review of data listings, summary tables, study results and scientific presentations.
• Present scientific information at scientific conferences as well as clinical study investigator meetings.
• Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus
• Discretionary stock-based long-term incentives (eligibility may vary based on role)
• Paid time off

What This Job Offers

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