Director, Clinical Development; Inflammation​/Fibrosis

Director, Clinical Development (Inflammation/Fibrosis)
United States - California - Foster City Clinical Development & Clinical Operations Regular

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

POSITION OVERVIEW:

As Director of Clinical development in the Inflammation/Fibrosis therapeutic area, you will lead or support multiple components of clinical trial programs, including primary biliary cholangitis (PBC) and/or other indications. You will be expected to provide scientific and clinical leadership or input on activities including study protocol preparation, other study or investigator documentation, medical monitoring, data analysis plans, study reporting, and clinical development input into regulatory documentation, publications, and scientific presentations.

Scope may include phase 3 and 4 studies with an opportunity to contribute across studies of other phases, as appropriate. The ideal candidate will have a strong scientific acumen; desire to work in fast-paced, matrixed environment; and drive to expand his/her skillset as needed to meet team goals.

This is a site based position at our Global Headquarters in Foster City, CA.

EXAMPLE RESPONSIBILITIES:

• Lead or support clinical trial protocol design, clinical study report development, and response to health authority inquiries
• Serve as medical monitor for clinical trials or oversee medical monitoring, including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality through data review as part of a cross-functional team
• Provide scientific and clinical guidance to cross-functional team members and colleagues to meet clinical development project deliverables and timelines
• Lead or support the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products
• Lead or support clinical development contributions in the preparation/review of regulatory documents, investigator brochures, and development plans
• Lead or support the collection and interpretation of data for internal analysis and review, ensuring high quality data and appropriate analyses performed
• Provide scientific and clinical leadership in the preparation, review, and interpretation of clinical trial data
• 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

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

• MD or equivalent with 4+ years’ clinical, scientific and/or drug development experience in the biopharma industry, academia, or a related environment
• Board certification in hepatology, gastroenterology is preferred; however, other backgrounds including pulmonology, rheumatology, or other internal medicine background with…