Manager, oPRB Administrator

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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.
We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
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. Join Gilead and help create possible, together.
Job Description
Job Title: Manager oPRB Administrator
Location: Foster City, CA; Parsippany, NJ; Raleigh, NC; Stockley Park, England; or Dublin, Ireland
Job Type: Full-Time
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. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of virology, including HIV/AIDS, hematology and oncology, inflammation and respiratory diseases. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients.
Job Description
Leveraging strong organization skills and scientific background, the Observational Study Protocol Review Board (oPRB) Administrator plays an integral part in ensuring scientific rigor and compliance in the development of observational studies across all Gilead functions. This role is in Gilead's Clinical Data Science Real-World Evidence (CDS-RWE) organization and reports to the oPRB Director. The oPRB Administrator will develop, integrate, manage, and continually improve processes for observational study quality and compliance. The oPRB Administrator also manages the cross-functional scientific review process for observational 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 and regulatory compliance. 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 leaders of the organization.
Key Responsibilities:
Leadership and Oversight:

• Oversee staff (ie., CW) who perform document submission for the Observational Study Protocol Review Board (oPRB)

• Assess the quality of protocol submissions and determining the appropriateness of the content and completeness
• Make go/no go decisions based on protocol submissions and provides tangible solutions and next steps for submissions with gaps
• Conduct protocol triage to guide submitters in selecting the appropriate review body(ies)
• 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 author

Process Management:

• Strategically plan, track, and facilitate the execution of evidence generation to maximize patient access to Gilead therapies
• Collaborate closely with RWE leadership to track evidence generation activities through the oPRB
• Develop and maintain oPRB submission site and portal
• Lead tracker updates and expansion to meet increasing need across the cross-functional submitters and reviewers
• Lead maintenance of the tracker, establish quality control procedures, ensure accuracy
• Lead quality control and documentation of oPRB activities to ensure audit readiness

Reporting and Communication:

• Lead development and generation of routine reports and metrics for the oPRB Director and RWE leadership
• Effectively communicate and disseminate reports to relevant stakeholders

Training and development:

• Create and maintain oPRB training documents for other oPRB administration staff and for oPRB reviewers
• Serve as the main point of contact to train new staff and new reviewers

Strategic Initiatives:

• Lead or operationalize key oPRB initiatives which include identification of project tasks, clear milestones, and assignments of work project responsibilities, schedules, plans, resources, and status reports

• Work with oPRB Director on critical pre-oPRB and post-oPRB processes including alignment with Clinical Trial Management System (CTMS), Regulatory Documentation System (RDS), and Trial Master File (TMF)
• Contribute to design and implementation of Gilead-wide end-to-end observational study tracking system

The successful candidate for this role will possess a wealth of experience in research administration and regulatory compliance. Demonstrated attention to detail, project management expertise, and effective communication with organizational leaders are essential attributes. Thriving in a complex, fast-paced, and matrixed organization, you will play a pivotal role in advancing evidence generation to showcase the value of Gilead therapies.
Basic Qualifications:

• Bachelor's Degree and Twelve Years' Experience

OR

• Masters' Degree and Five Years' Experience

OR

• PhD and Three Years' Experience

Preferred Qualifications:

• Collaborative communication skills and concise technical writing skills
• Leadership in strategic planning and execution with strong operational rigor and resourceful thinking
• Strong prior project management experience, including attention to detail and organization skills and experience working with global market access teams
• Experience with shared collaboration spaces (Teams/SharePoint)
• Expertise in analytic and visualization tools for reporting and data synthesis
• Proven track record of cross-functional collaboration within a matrix organization and successfully managing complex, time-sensitive, transformational projects
• 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

The salary range for this position is: $133,280.00 - $172,480.00. 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:
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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.