Director, Patient Safety, Ta Safety Physician

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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Job Description
You will develop and ensure that strategic medical input relative to safety is incorporated into product development and lifecycle management as well as perform other advanced MSS activities for one or more products in the assigned therapeutic area.
You will provide strategic input into cross-functional drug development planning and execution across the product lifecycle, from discovery to postmarketing. You will ensure that signal detection, development of benefit-risk evaluation management plans, risk minimization activities, and aggregate safety reports are performed in a timely and quality manner. You will also provide input on behalf of MSS into study-related activities and documentation, regulatory submissions, responses to regulatory agency inquiries, pharmacovigilance (PV) processes and projects, and PV or other audits and inspections. You may be assigned responsibilities as the Safety Lead (SL); acting as the expert, go-to person regarding the safety profile of a product/compound or group of products/compounds. You will play a lead role within MSS by contributing to the ongoing and continuous improvement and advancing capabilities of the function.
EXAMPLE RESPONSIBILITIES:

• Accountable for the successful oversight and completion of a broad spectrum of MSS activities and deliverables for one or more products, compounds or indications in the assigned TA, in compliance with established practices, policies, processes, and any regulatory or other requirements.

• Advises other functions on short- and long-range MSS strategies, plans, resources and tactics.
• Performs or otherwise oversees safety reviews of clinical trial protocols, clinical study reports, informed consent forms, and other study related documents.
• Provides medical input on the PV activities for products within the assigned TA.
• Contributes to and/or oversees the preparation of aggregate safety reports and risk management plans (RMPs).
• Conducts and/or oversees signal detection and evaluation activities for assigned products as part of the continuous benefit-risk evaluation throughout the product lifecycle.
• Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator's Brochure and other key safety documents and deliverables.
• Contributes to and/or oversees MSS activities and input related to regulatory filings (e.g., Marketing Authorisation Applications [MAAs], New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.
• Participates on Patient Safety (PS) and cross-functional teams, including leadership of special projects, participation in continuous improvement and optimization initiatives, and MSS functional area support in PV audits and inspections.
• May serve as medical monitor for post-authorization safety studies.
• May have one or more direct reports.
• Provides matrix management and leadership to project teams.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
U.S. Education & Experience

• MD/DO degree or equivalent with 4+ years' relevant experience.
• Completion of an accredited medical or surgical residency program.
• Board certification is strongly preferred.
• Experience in HIV clinical care preferred, but not required.
• Experience in drug safety signal detection, benefit-risk evaluation and authoring drug safety risk management plans and aggregate safety reports is preferred.

Rest of World Education & Experience
MD / DO or equivalent with completion of an accredited medical or surgical residency program. Board certification is strongly preferred. Experience working in drug safety / PV or a related field in the biopharma industry, clinical research, health administration, health policy, epidemiology, or academic or subspeciality medicine.
Knowledge & Other Requirements

• Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
• Strong negotiation and conflict resolution skills.
• Strong coaching capabilities to mentor/develop staff.
• When needed, ability to travel.

The salary range for this position is: $230,860.00 - $298,760.00. 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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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.