For Current Gilead Employees and Contractors:

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At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Specific Responsibilities:

• Function as the Medical Monitor for Post Authorization Studies (PAS) that are assigned to PS for the purposes of regulatory commitments.
• Collaborate with the SMEs for the products to assure an understanding of the necessary data to be collected and Adverse Events of Interest for the compound in the PAS.
• Collaborate cross functionally in the PAS study design.
• In collaboration with the CRO develop the medical monitoring plan (MMP) for the PAS.
• Collaborate cross functionally and proactively if based on prior regulatory requests a PAS can be predicted to be necessary for marketing authorization.
• For studies collecting data on the same compound look for opportunities to standardize the data collected and the methods of collection within the studies, to achieve efficiencies.
• Contributes to preparation and review of safety documents, regulatory inquiries, study reports and SAP
• Contributing to manuscripts, abstracts, and scientific presentations as necessary.
• Participates in audits, data analysis, and other ad hoc activities.
• Oversee CRO safety related activities to assure contractual agreements are being met and provide medical input on escalated issues as needed.
• Communicate with compound SMEs regarding PAS progress for the purposes of aggregate reports, RMPs regulatory communications.  
• Contribute to PAS process improvements.

Essential Duties and Job Functions:

• Provides medical safety oversight of the PAS, CRO and sign off on safety documents, collaborate within PS and cross functionally to ensure the studies meet the regulatory request and CROs meet contractual agreements. 
• Performs monitoring of the study CRO, medical evaluation of data as needed, review of study reports, medical monitoring plans and monitoring for safety signals.
• Keep compound SMEs informed of the study progress, issues, and findings.

Knowledge, Experience and Skills:

• Requires an MD/DO degree or equivalent
• Requires completion of an accredited medical or surgical residency program. Board certification is preferred.
• Should have an exceptional track record of excellence in clinical practice in a medical specialty
• Should have an excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
• Ability to communicate to high level stakeholders under tight deadlines and to manage multiple major projects simultaneously
• Ability to develop cross functional relationships with RWE, Med Affairs, Clinical Operations, work with CROs, understand roles and responsibilities, and review data. 
• Necessary to have experience in post marketing pharmacovigilance, signal detection and evaluation, review of study reports, work collaboratively in a cross functional setting and attention to detail. 
• Preferred to have experience with drug approval and regional post authorization requirements.

The salary range for this position is: $266,815.00 - $345,290.00. 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.

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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 [email protected] for assistance.
 

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

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For Current Gilead Employees and Contractors:

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