Senior Director, Real World Evidence - Virology

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
 

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting millions of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Senior Director, RWE Virology Safety Epidemiology Lead

Position Description

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. The Senior Director, RWE Virology Safety Epidemiology Lead reports to the Executive Director, RWE Therapeutic Area Head-Virology and has primary accountability for the execution of post authorization and other non-experimental studies, both mandatory and voluntary, in support of Virology product safety. The incumbent 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 strategic partner to the RWE Virology Product Area Leads and cross-functional stakeholders to ensure excellence in the execution of all safety epidemiology activities at the global level.

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

Success in this role requires excellence in design and conduct of epidemiologic studies, expertise in the use of data from both primary as well as secondary sources (e.g., from administrative claims, medical records, etc.), expertise in the use and application of appropriate and state-of-the-art analytical methods at different stages of the product development and commercialization lifecycle, and the ability to lead and manage cross-functional efforts and resources.

Duties & Responsibilities

• Serve as the primary point of accountability for the timely development, execution, and communication of specified post-authorization/non-experimental studies for the safety of 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 PMC study protocols and analysis plans developed internally and externally.
• Ensure collaboration and coordination of Safety Epidemiology activities with RWE Virology Product Area teams.
• Lead a team of observational research scientists within a matrix organization to deliver, within time, budget, and quality standards, safety-related studies including,