Executive Director, Clinical Development (Pediatrics)

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.

• 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

EXAMPLE RESPONSIBILITIES: 

• 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 dir