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, but not limited to: patient registries, signal evaluation studies using secondary data, drug utilization studies, comparative safety studies, and post-approval 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 cross-functional 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 master’s 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, post-graduation 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 state-of-the-art 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 post-authorization 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 cross-functional 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. + Well-developed cross-cultural sensitivity. The salary range for this position is: $261,375.00 - $338,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf) YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.