Job 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 fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) department within the Clinical Development organization and aims to unlock the power of Real-World Data (RWD) to help transform innovations to life-changing medicines for patients. The Director, RWE Oncology reports to the Senior Director, RWE Oncology Pharmacoepidemiology and Safety Lead and contributes to the development and execution of the RWE strategy in support of an Oncology Franchise through oncology product development and commercialization. The incumbent will serve as an RWE pharmacoepidemiology and safety subject matter expert for Oncology interacting with pertinent indication sub-teams of the Global Development Team (s) (GDT) for the Franchise(s) and a strategic partner to clinical development, medical, patient safety, and commercial teams by the generation of RWE at the global level.
The Director, Real-World Evidence (RWE) Oncology Pharmacoepidemiology and Safety will design and deliver RWE required by internal stakeholders and regulators, ensuring timeliness, quality, and utility, as well as advise on methodological approaches including support of payer and provider interactions.
Success in this role requires a strong track record in the design and conduct of post authorization safety studies, rapid analyses to address ad hoc epidemiologic queries /analyses, direct expertise in use of RWE at different stages of the product development and commercialization processes, including early- stage clinical development, and the ability to manage effort and resources in a cross-functional, matrix setting.
Job Description:
Duties & Responsibilities:
- Serve as the single point of accountability for the timely development, execution, and communication of specified pharmacoepidemiology and safety studies for individual products and their pipeline/lifecycle indications in Oncology.
- 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 Pharmacovigilance and Safety analysis plans developed internally and externally.
- Ensure collaboration and coordination of Pharmacovigilance and Safety projects within RWE Oncology Product teams
- Work within a matrix organization to deliver, within time, budget, and quality standards, post-authorization studies including, but not limited to: patient registries, studies of natural history of disease, drug utilization studies, studies of patient reported outcomes, comparative effectiveness/safety studies, and post-approval safety studies.
- Ensure fulfillment of observational study conduct requirements, such as registration, ethical board approval, protocol, SAP, study report development, and disclosure.
- Communicate effectively about the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions.
- Contribute to the communication of observational research results, including development of pertinent sections of regulatory documents, publications, white papers.
- Contribute to timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide (e.g., Risk Management Plan, orphan or breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing documents).
- Represent the RWE function in internal cross-functional teams and initiatives.
- Leverage close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as in Clinical Research, Patient Safety, Medical Affairs, and Global Value and Access to anticipate and meet the evidence needs of regulators, payers, providers, and patients.
- Identify the need for and contribute directly to the development of processes and delivery of training aimed at increasing the efficiency, quality, and impact of functional activities.
- Mentor junior epidemiologists and RWE analysts to ensure competence in epidemiologic skills and knowledge.
Requirements:
- Doctoral degree (e.g. PhD, MD, ScD, PharmD) and/or Master's degree (e.g. MSc, MPH) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of 8 years (PhD) or 10 years (MS) of relevant experience. Preference for a minimum of six (6) years of that experience to be in the biopharmaceutical industry.
- Direct experience with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and/or safety commitments.
- Experience designing and conducting observational research, including protocol, statistical analysis plan, and study report development.
- Experience with secondary data analysis, including electronic medical record and/or medical claims databases, and with statistical analysis tools, such as SAS and R.
- A track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred.
- Preference for understanding of the Oncology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
- Experience leading studies and projects in a matrix setting.
- Demonstrated ability to function with autonomy and develop productive cross-functional collaborations.
- Ability to manage priorities, resources, and performance targets.
- Well-developed cross-cultural sensitivity.
The salary range for this position is: $205,615.00 - $266,090.00. 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.