Associate Director​/Director, Clinical Development; MD

Associate Director/Director, Clinical Development (MD)

Location:

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

At Gilead Sciences, we’re driven by our mission to discover, develop, and deliver innovative therapeutics that improve the lives of patients worldwide. Our Legal Operations team plays a critical role in enabling the Legal department to operate efficiently, strategically, and in alignment with Gilead’s values of integrity, inclusion, teamwork, and excellence.

You will typically lead multiple components of clinical trial programs in immunology clinical development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, 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.

This is a site-based role at our global headquarters in Foster City, CA. We offer a hybrid environment with optional Mondays and Fridays the ability to work from home.

• Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules/products.
• Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
• Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
• Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
• Coordinates the collection and assimilation of ongoing data for internal analysis and review.
• Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
• Presents scientific information at scientific conferences as well as clinical study investigator meetings.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

Minimum education and experience and related qualifications for this role are described below.

• MD or equivalent with 2+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• Experience in phase 1 and 2 clinical trials is preferred.
• Board certification in rheumatology/dermatology/gastroenterology or allergy and immunology is preferred, including familiarity with systemic autoimmune diseases.
• Experience in the biopharma industry is preferred.
• Experience…