Senior Director Real World Evidence - Virology
Senior Director Real World Evidence - Virology
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$ 261375 - 338250
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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 researchbased biopharmaceutical company founded in 1987. Together we deliver lifesaving 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 latestage 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 lifethreatening diseases.
Senior Director RWE Virology Safety Epidemiology Lead
Position Description
The RealWorld 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 RealWorld Data (RWD) to help transform innovations to lifechanging medicines for patients. The Senior Director RWE Virology Safety Epidemiology Lead reports to the Executive Director RWE Therapeutic Area HeadVirology and has primary accountability for the of post authorization and other nonexperimental 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 crossfunctional stakeholders to ensure excellence in the 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 stateoftheart analytical methods at different stages of the product development and commercialization lifecycle and the ability to lead and manage crossfunctional efforts and resources.
Duties & Responsibilities
- Serve as the primary point of accountability for the timely development and communication of specified postauthorization/nonexperimental studies for the safety of individual products and their pipeline/lifecycle indications in Virology.
- Provide functional perspective and subjectmatter 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 safetyrelated studies including but not limited to: patient registries signal evaluation studies using secondary data drug utilization studies comparative safety studies and postapproval safety studies.
- 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 including development of study reports and pertinent sections of regulatory documents publications white papers press releases etc.
- Represent the RWE function in internal crossfunctional initiatives and external organizations such as industry associations professional societies or regulatory working groups.
- Foster close collaborations with quantitative functions within CDS (e.g. Biostatistics Clinical Pharmacology AI/ML Research Center) as well as partners in Clinical Development Global Patient Safety Regulatory Affairs Clinical Operations Medical Affairs and Global Value and Access to anticipate and meet the evidence needs of regulators payers providers and patients.
- Actively identify the need for the development of processes or gaps in training documents aimed at increasing the efficiency quality and impact of functional activities.
Requirements
- Doctoral degree (e.g. PhD MD ScD PharmD) and/or masters degree (e.g. MSc) in Epidemiology or related discipline such as Outcomes Research Medicine Biostatistics from an accredited institution with a minimum of twelve 12 years of relevant postgraduation experience; preference for a minimum of six 6 years of that experience to be in the biopharmaceutical industry.
- A strong track record of scientific publications demonstrating expertise in observational study design analysis and interpretation and direct experience with different applications of RWE especially in support of PAS.
- Preference for understanding of the Virology therapeutic area including disease knowledge current treatment practice and guidelines pertinent clinical trial endpoints and safety outcomes.
- Strong preference for expertise in stateoftheart methods including AI/ML approaches for leveraging RWD to assess safety and other questions.
- Solid working knowledge of regulatory guidelines pertaining to RWD and RWE studies especially postauthorization studies.
- Experience leading coaching and managing people in a global matrixed setting.
- Demonstrated ability to function with a high level of autonomy and develop productive crossfunctional collaborations.
- Ability to manage priorities resources and performance targets in a changing environment.
- Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.
- Welldeveloped crosscultural sensitivity.
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Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Exec
Employment Type
Full-Time
