Senior Director, Obs Studies, Medical Affairs Research

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.

Medical Affairs Research is a core strategic function within Global Medical Affairs, providing scientific leadership and evidence generation across the product lifecycle. As a team within MAR, the Post-Authorization Research & Innovation in Study Methodology (PRISM) drives the selection and implementation of state-of-the-art research methodologies for post-authorization (Phase 4) medical affairs research across therapeutic areas.  The Senior Director RWE for PRISM reports to the Executive Director of PRISM and will serve as the key subject matter expert for the scientific and operational execution of RWE studies, as well as hybrid studies.   

You will partner closely with the MAR Therapeutic Leaders to define asset-appropriate lifecycle evidence strategies and ensure their integration into Integrated Evidence Plans (IEPs). As a senior Medical Affairs leader, you will influence enterprise governance, shape cross-functional decision-making, and represent Medical Affairs perspectives on research innovation, feasibility, and impact.  Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations. 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.

Provide functional perspective and subject-matter expertise on RWE methods and requirements at both the MAR and Regional/Affiliate Medical Affairs TA level, including review of study protocols and analysis plans developed internally, in study collaborations and submitted as Investigator Initiated Research Partner with Clinical Development, Regulatory Affairs, Patient Safety, HEOR, and Commercial colleagues.

Key Responsibilities:

• Communicate effectively about the utility of RWE and drive use of study results to support internal and external decisions.

• Ensure expert communication of observational research results supported by MAR, including development of study reports and pertinent sections of regulatory documents, publications, white papers, press releases, etc.

• Foster close collaborations and align processes with key internal partner functions, including CDS-RWE, HEOR, Biostatistics and AI/ML Research Center.

• Partner effectively with Clinical Development Therapeutic Areas, Clinical Operations, Regulatory Affairs, Patient Safety, and Commercial colleagues.

• As assigned, leads or otherwise oversees and directs the study protocol design, execution and reporting.

• Ensure compliance with global regulatory requirements, patient safety standards, GCP, and Gilead policies.

• Establish