Director, Clinical Development (MD)

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 our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

The Director, Clinical Development provides clinical leadership and input on clinical studies, supporting the HIV programs. You will typically lead or assist on multiple components of clinical trial programs in HIV clinical development. You will help design, conduct, and evaluate Phase 1-4 clinical trials and provide expertise in clinical hepatitis. You will primarily be involved in developing drugs for HIV treatment and cure. Working in collaboration with the Clinical Leads and Global Development Team Leads, you will be responsible for various aspects of ongoing clinical trial program-related activities within the HIV therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start up/execution/close out, specifically including, medical monitoring, data analysis/reporting and support of Regulatory filings, and clinical development input into regulatory documentation, publications, and scientific presentations.

Key Responsibilities:

• This position reports to the Executive Director of HIV Treatment and Cure.
• 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 proto‐col design, clinical study reports and health authority inquiries. Provides ongoing clinical monitoring for clinical trials, including but not limited to 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.
• Provides high level and complex scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines.
• Primary responsibilities include providing high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries.
• Provides ongoing clinical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
• Also manages the clinical research component in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans.
• Coordinates the collection and assimilation of ongoing data for internal analysis and revi