Internship Real World Evidence Rwe Jobs in Hackensack, NJ

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Job Description

The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group 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.

We are seeking a Senior Director, RWE Inflammation Product Lead who will be accountable for the development and execution of the RWE strategy in support of one or more Inflammation products under development. The incumbent will serve as the key RWE subject matter expert within Gilead's lifecycle management teams for the product(s) and all its indications across the development lifecycle and serve as a strategic partner to clinical development, medical, and commercial teams to ensure excellence in the generation and use of RWE at the global level.

The SD, RWE Product Lead will provide leadership for a team of observational research scientists and advocate for the appropriate level of resources to ensure the timeliness, quality, and utility of RWE required by internal and external stakeholders (e.g., clinical development, regulators), as well as advise on methodological approaches in support of payer and provider interactions.

Success in this role requires a up-to-date knowledge of RWE/RWD use for regulatory purposes, a strategic mindset, and the ability to lead and deliver RWE strategies through strong cross-functional partnerships and external collaboration.

This role also requires excellence in 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 lead and manage cross-functional efforts and resources.

The Senior Director, RWE Inflammation Product Lead reports to the Executive Director, RWE Therapeutic Area (TA) Head-Inflammation

Duties & Responsibilities

• Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting clinical development and regulatory submissions for a specific product/program and its pipeline/lifecycle indications in Inflammation.

• Ensure the use of robust scientific methods and fit-for-purpose data resources for the timely execution of the RWE strategy, in alignment with the clinical development plan and broader DET/EMT objectives.

• Provide the functional perspective and subject-matter expertise, especially regarding regulatory use of RWE, as a member of the product DET/EMT.

• Provide leadership for a team of observational research scientists to deliver, within time, budget, and quality standards, proactive RWE generation 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-approval safety studies.

• Communicate effectively about the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions.

• Ensure expert communication of observational research results, including development of pertinent sections of regulatory documents, publications, white papers, press releases, etc.

• Oversee 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 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, Bioinformatics), as well as in Research, Clinical Research, 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.

Minimum Required Education and Years of Experience

• Bachelor's Degree and Fourteen Years' Experience OR

• Masters' Degree and Twelve Years' Experience OR

• PhD and Twelve Years' Experience

Preferred Qualifications:

• Doctoral degree (e.g. PhD, ScD) and/or Master's degree (e.g. MSc) in Epidemiology 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 doctoral degree in epidemiology with leadership experience and primary focus on epidemiology evidence generation, especially for clinical development support, regulatory submission and safety are preferred.

• 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 early-stage clinical development and regulatory approvals.

• Demonstrated experience in leading the development and execution of integrated RWE strategies to support clinical development programs, including alignment of evidence generation plans with overall development objectives.

• Demonstrated experience in providing strategic RWE leadership for regulatory filings/submissions, and interactions with global health authorities, including oversight of observational study design, analysis, and interpretation to support benefit-risk assessment, labeling discussions, and safety evaluations across development stages.

• Demonstrated understanding of the Inflammation therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.

• Experience leading, coaching, and managing people in a global 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.

People Leader Accountabilities:

• Create Inclusion -knowingthe business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to grow,developand realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is:

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.

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.comfor assistance.

For more information about equal employment opportunity protections, please view the'Know Your Rights' poster.

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