Director- Real World Evidence (RWE) Oncology, Breast Cancer

Gilead Sciences, Inc.; Washington (District of Columbia); On-site; USD 226,000 - 293,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Director of Real-World Evidence in Oncology. This role involves designing and delivering RWE strategies, managing cross-functional teams, and ensuring quality in evidence generation. The ideal candidate will have a strong background in epidemiology and oncology, with significant experience in the biopharmaceutical industry. Join us to make a meaningful impact on patient outcomes.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Medical, dental, vision, and life insurance

Qualifications

• Minimum of 8 years (PhD) or 10 years (MS) of relevant experience.
• Experience in biopharmaceutical industry preferred.

Responsibilities

• Develop and execute global RWE strategy for oncology products.
• Generate real-world evidence to support clinical development.
• Communicate RWE findings to stakeholders.

Skills

Epidemiology

Oncology

Cross-functional collaboration

Statistical analysis

Education

Doctoral degree in Epidemiology

Master’s degree in Epidemiology

Tools

SAS

R

Job description

Director- Real World Evidence (RWE) Oncology, Breast Cancer page is loaded

Director- Real World Evidence (RWE) Oncology, Breast Cancer

Apply locations United States - California - Foster City United States - District of Columbia - Washington United States - New Jersey - Parsippany time type Full time posted on Posted 7 Days Ago job requisition id R0045182

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 Director, Real-World Evidence (RWE)- Oncology 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 epidemiologic studies/analyses, direct expertise in use of RWE at different stages of the product development and commercialization processes, and the ability to manage effort and resources in a cross-functional, matrix setting.

Duties & Responsibilities:

• Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting early-stage clinical development and post-authorization evidence requirements for one or more pipeline/lifecycle indications for products in Franchise(s) in Oncology.
• Employ robust scientific methods and fit-for-purpose data for the timely execution of the RWE strategy, in alignment with the clinical development plan and broader GDT objectives.
• Generate, within time, budget, and quality standards, real-world evidence including, but not limited to: natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization 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.
• Knowledge of the Oncology therapeutic area.
• 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: $226,185.00 - $292,710.00. 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 [e-mail] for assistance.

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Please apply via the Internal Career Opportunities portal in Workday.

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