Executive Director, Clinical Development (Pediatrics)

Gilead Sciences • Foster City, CA

1d • $295,120 - $420,090 • Remote

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 This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for viral infectious diseases for children. The Executive Director, Clinical Development, will provide expertise in pediatric drug development and oversee the design, conduct, and evaluation of Phase 1, 2, and 3 clinical trials. You will lead a portfolio of pediatric programs in virology clinical development for HIV treatment and PrEP, viral hepatitis, viral respiratory diseases, and other antiviral indications. You will supervise Pediatric Development Leads across the assigned project portfolio. You will be accountable for the design, conduct, evaluation, close-out and reporting of clinical trials across your project portfolio. You will lead or otherwise oversee and direct the development, implementation, and execution of the pediatric clinical development strategy for the assigned molecules / products, which will include development of the Pediatric Clinical Development Plans and input into Target Product Profiles, as applicable. You will liaise robustly with the Gilead Asset Teams and support the Pediatric Development Leads as they liase with the Development Evidence Teams. Additional leadership or oversight responsibilities include, but are not limited to, clinical development inputs into regulatory documentation, publications, and scientific presentations. This is an opportunity to help ensure our innovative medicines are tailored to and studied in and approved for pediatric populations. This position is located in Foster City, CA at our global headquarters. We will also consider higly qualified remote employees. KEY RESPONSIBILITIES The executive director will serve as Pediatric Head and play a key role in all stages of pediatric development for product programs.

Requirements

• MD or equivalent with 8+ years’ experience OR MS, PharmD or PhD in clinical research or clinical pharmacology with 14+ years’ experience in drug development in the biopharma industry
• Experience in pediatric drug development is strongly preferred; experience performing clinical research studies in HIV treatment or prevention, viral hepatitis, respiratory or other viral diseases is also an asset.
• Extensive experience leading high-complexity cross-functional drug development strategies and plans, including short- and long-range strategic planning, governance, and oversight.
• Extensive experience taking the lead on clinical study plans, protocol design, regulatory filings, clinical publications, and presentations.
• Understanding of Clinical Pharmacology/Clinical Pharmacokinetics principles and familiarity with using modeling and simulation to support pediatric drug development
• Line management (direct reports) experience of at least 5+ years in in drug development in the biopharma industry is required.
• Extensive experience interacting with and presenting to executives is strongly preferred.
• Has an expert-level of knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans.
• Leadership experience with cross-funcational organizations and strong EQ.
• Has thorough understanding of pharmaceutical regulatory requirements for pediatric drug development globally and impact on development and execution of clinical trials.
• Strong leadership skills with an ability to set vision, lead change, and mentor others.
• Ability to work effectively in a multidisciplinary, cross-functional team team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
• Strong communication and organizational skills.
• Able to distill complex matters into a clear business case and roadmap for execution.
• Demonstrated ability to lead by influence and align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives.
• When needed, ability to travel 8-12 times a year both domestically and internationaly (depending on final work location)

Responsibilities

• Strategic input and oversight for pediatric development programs
• Oversee development and execution of Phase 1, 2, and 3 clinical trials and provide scientific expertise
• Serve as a resource for pediatric drug development for Clinical Development and cross-functional areas
• Liaise and engage between the pediatric teams and the Gilead Asset Teams and support the Pediatric Development Leads in engaging with the Development Evidence Teams
• Leadership role in clinical strategy and execution of all pediatric virology programs including collaboration with Vice Presidents in Virology (Department Review Committee Chairs) and Development Evidence Leaders for molecules / products
• Represents or oversee representation for the assigned molecules / products in cross-functional steering and /or governance committees
• Manages direct reports as Pediatric Development Team Leaders to ensure clinical development project deliverables and timelines are consistently met
• Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / products
• In general, provides oversight for communications, both written and oral, with health authorities
• Oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance
• Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents including pediatric investigation plans (PIPs) and pediatric study plans (PSPs)
• Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations
• Presents or oversees presentations of scientific information at scientific conferences as well as clinical study investigator meetings; where applicable, takes a lead on authoring scientific publications
• Key insight and involvement in the evaluation of pediatric aspects of business development opportunities
• Develops thought leader and other external relationships that can guide short- and long-range pediatric clinical development strategies and direction for multiple molecules, the disease or therapeutic area overall
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs
• Provides scientific and clinical guidance to Research, Biology, Virology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff, as applicable
• May lead two or more specific components of organizational strategic initiatives.

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.

What This Job Offers

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