Director, RWE Virology Safety & Epidemiology

Description

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 fulfill their aspirations. Join Gilead and help create possible, together.

AtGileadour 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. As a Director in Real-World Evidence at Gilead you will-

Work in a team of observational research scientists within a matrix organization and advocate for the appropriate level of resources and methods to ensure the timeliness, quality, and utility of RWE Virology activities in support of safety required by internal and external stakeholders (e.g., regulators).

Report to the Senior Director, RWE Safety Therapeutic Area Lead-Virology and are responsible for the execution of RWE safety epidemiology studies across the product lifecycle, including pediatrics, post authorization studies (PAS), and other non-experimental studies, both mandatory and voluntary, in support of Virology products.

Will serve as the key subject matter expert for Virology post marketing commitments (PMCs) and other pharmacoepidemiology activities in support of safety and serve as a partner to the RWE Virology Product teams and cross-functional stakeholders to ensure excellence in the execution of all safety epidemiology activities at the global level.

The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Development organization and aims to unlock the power of Real-World Data (RWD) to help transform innovations to life-changing medicines for patients.

Success in this role requires a strong track record in the design and conduct of epidemiologic studies, direct expertise in use of RWE and application of adequate and contemporary analytical methods across drug development, including pediatrics and post-authorization phase of the product development and commercialization processes, and the ability to manage efforts and resources in a cross-functional matrix setting.

• Responsible for the development, execution, and communication of specified RWE safety / non-experimental studies for individual products and their pipeline / lifecycle indications in Virology.
• Provide functional perspective and subject‑matter expertise on RWE methods and requirements at both the global / regional level and the TA level, including review of RWE safety and PAS protocols and analysis plans developed internally and externally.
• Collaborates and coordinates safety, pediatrics, and PAS activities with RWE Virology Product teams.
• Employ robust scientific methods for the timely execution of safety, pediatrics, and PAS strategy in alignment with pipeline / lifecycle management objectives.
• Lead or contribute to a team of observational research scientists within a matrix…