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Director, RWE Scientific Review Board

Employer
Gilead Sciences, Inc.
Location
Morris Plains, NJ
Start date
Aug 11, 2022
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Job Details

Director, RWE Scientific Review Board
United States - New Jersey - Morris Plains

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Job Description
RWE Scientific Review Board Director

Located in Foster City, CA or Morris Plains, NJ

Additional Locations:

Seattle, WA | Raleigh, NC | Stockley Park, UK | Dublin, Ireland |

Leveraging strong organization skills and scientific background, the RWE Protocol Review Board Director plays an integral part in ensuring scientific rigor and compliance in the development of real-world evidence. This role is in Gilead's Clinical Data Science Real-World Evidence (CDS-RWE) organization and reports to the head of CDS-RWE Generation. The Director will develop, integrate, and continually improve processes for RWE study quality and compliance. The Director also coordinates the cross-functional scientific review process for RWE protocols. This is a complex role vital to the tracking and execution of evidence generation to demonstrate the value of Gilead therapies. The successful candidate is experienced in research administration, regulatory compliance, and the uses of RWE in clinical development and safety endeavors. They have demonstrated attention to detail, project management expertise, and the ability to thrive in a complex, fast paced, matrixed organization. Additionally, the ideal candidate will have the proven ability to effectively communicate to senior leaders of the organization.

Core Responsibilities
  • Matrix management of the project and process management of the Real-World Evidence Protocol Review Board including
    • Assessing the quality of protocol submissions and determining the appropriateness of the content and completeness
    • Makes go/no go decisions for the next step and provides solutions and next steps for submissions with gaps for the RWE researchers
    • Initiate the scheduling of review meetings, including determination of the relevant cross-functional and ad hoc members according to subject matter expertise required for specific submissions, and assignment to urgent review process (if required)
    • Ensure timely feedback from subject matter expert reviewers to the analysis author
    • Lead quality control and documentation of RWE PRB activities to ensure audit readiness
  • Work closely with Head of RWE Generation and study leads to track evidence generation activities in the appropriate system(s)
  • Serve as compliance liaison for RWE, including managing responses to process deviations, proactive process improvements, and staff training
  • Lead process management, change management and alignment with IT for RWE scientific operations and updates
    • Lead strategy for system updates and expansion to meet increasing need across the multidisciplinary RWE team, problem solving for competing needs
    • Lead periodic maintenance of study tracking and reporting systems
    • Lead execution, oversight and auditing aligned with the Standard Operating Procedures
  • Lead development and generation of reports and metrics for the Head of RWE Generation
    • Solution driven approach for continuous quality improvement of RWE activities
  • Lead development of communications strategy and preparation/content including RWE process trainings and project/initiative presentations
  • Contributes to the RWE budget process
  • Lead some key RWE Generation initiatives with cross-functional partners


Capabilities and Requirements
  • Strong organizational management skills, including attention to detail and cross-functional communication
  • Strong leadership and communication skills across functions and leadership teams; comfort in business and technical discussions. Able to influence without direct authority
  • Expertise in development and administration of systems for study tracking and reporting
  • Highly resourceful and strategic thinker with strong emotional intelligence and operational rigor
  • Proven track record cross-functional collaboration withing a matrix organization and successfully managing complex, time-sensitive, transformational projects
  • Proven track record of simultaneously managing multiple projects
  • Previous administrative and organizational development experience in RWE or clinical research
  • Expertise with RWE research disciplines, such as epidemiology and data science
  • The ideal candidate will have demonstrated leadership in strategic planning and execution
  • Experience driving large initiatives from framing the problem, conducting research / analysis to building the business and operational plans through to driving execution to success is required
  • Self-starter who thrives in a fast-paced, collaborative, and innovative high-growth environment
  • Limited travel
  • A minimum of (9) years' relevant experience with a Bachelor's Degree or at least (7) years' experience with an advanced degree (PhD, MPH)
  • Advanced degree in a scientific field relevant to RWE (e.g., epidemiology, public health, data science, clinical research) preferred



For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

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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 log onto your Internal Career Site to apply for this job.






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Company

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Find Us
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States
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