Director, Global Patient Safety (GLPS Standards & Collaborations)

Director, Global Patient Safety (GLPS Standards & Collaborations)
United States - California - Foster City

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

The Global Patient Safety (GLPS) department is a global function that is part of the Development organization within Gilead. The main Pharmacovigilance activities of GLPS are centered at three sites: Foster City and Santa Monica in the USA and Cambridge in the UK. GLPS is organized within four distinct areas:

• GLPS Operations: Responsible for case processing from receipt through to submission to external parties and operational support of clinical studies.
• Medical Safety Science: Covers the medical input and scientific evaluation of safety data including ICSRs, aggregate data, risk management plans, aggregate reports and signal detection.
• EU QPPV Office: EU QPPV and deputy EU QPPV responsibilities
• Standards and Collaborations (S&C): Responsible for review of PV-related policies and global regulations, PV Alliance management and PV Agreements, Solicited Programs and Risk Evaluation and Mitigation Strategies (REMS) management, audit and inspection readiness/support, training, performance and quality measures, PV support for Affiliates and Distributors and the team where this role will sit.

Gilead Sciences is seeking an ambitious individual to join the S&C team as a Director responsible for leading overall REMS program management and providing subject matter expertise to leadership team. This is a small team, with primary responsibilities involving close collaborations with internal/external partners in order to meet compliance with FDA REMS requirements. This position requires excellent leadership, business partnering, and activity planning/sequencing and strategic influencing skills.

Essential Job Duties and Functions:

• Leads strategic planning for development and/or revision of REMS process workflow and REMS related procedure documents in addition to participating strategic planning for the wider GLPS organization.
• Utilizes excellent operational and project management skills to lead and provide close oversight over all assigned REMS programs.
• Directly or indirectly manages ongoing REMS program commitments/ department-wide initiatives by collaborating with key stakeholders including but not limited to, Regulatory, GLPS, Commercial, Medical Affairs, Legal, IT and external vendors
• Leads and represents REM project teams/working groups to the GLPS Leadership or Program Steering Committee. Organizes preparation of complex documents for review by the GLPS Leadership or Program Steering Committee for projects within GLPS
• Oversees and actively contributes to preparation/review of REMS related documents in response to FDA. Authors and/or provides key safety input into all applicable REMS submission documents.
• Ensures compliance with REMS program commitments including team compliance with internal processes to meet all applicable internal/external reporting requirements and training for internal/external groups on REMS-specific requirements.
• Manages implementation related activities for REMS including but not limited to; training and/or on-boarding activities, preparation and training materials for website and print material verifications following FDA approval of an initial REMS or program modification to ensure compliance
• Ensures REMS vendors adequately perform their contractual activities including periodic training on AE reporting process and REMS-specific requirements
• Leads cross-functional projects/department-wide initiatives and serves as a point of contact to other functions in the organization and outside the organization
• Leads and develops effective training on drug safety or other related training to internal groups or CROs. Supports external events on training as subject matter expert
• Reviews new regulatory requirements in area of responsibility, makes recommendations based on impact to existing processes and oversees implementation
• Leads audit or inspection activities in the area of expertise and tracks corrective actions; provides support in internal and external audits and inspections as required
• Understands and manages the execution of company and department Business Continuity processes
• May recruit, hire, mentor, and manage direct reports, with responsibility for employee performance evaluations
• May participate in budget planning and management.

Job Skills:

• Demonstrates strong leadership and organization skills in managing multiple, complex, time sensitive tasks within team and GLPS ensuring adherence to timelines.
• Exhibits higher knowledge of pharmaceutical industry, with emphasis on the regulatory environment.
• Excellent knowledge and understanding of role and the broader impact across GLPS and other departmental activities. Competent in abilities in area of expertise and the wider areas of pharmacovigilance/GLPS.
• Demonstrates excellent scientific/clinical or analytical knowledge base, with ability to assess data and understand the safety/medical or process implications
• Demonstrates excellent verbal and written communication skills; has ability to provide direction to a team, and to influence peers and team members appropriately
• Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines
• Identifies and pursues global and long-term goals for the group, in collaboration with department head, taking into account and providing support for the strategic goals of the organization
• Ability to effectively represent GLPS on multidisciplinary teams
• Ability to provide constructive feedback in a timely manner high-energy and fast paced environment
• Strong experience with managing vendors, partners including specialty pharmacies, external PMO's highly preferred
• Identifies and develops solutions to complex problems which require the regular use of ingenuity and innovation, ensuring solutions are consistent with organization and Gilead objectives.
• Develops solutions to a wide range of complex problems which require the regular use of ingenuity, creativity, and innovation, ensuring solutions are consistent with organization objectives; develops concepts, techniques, standards, and new applications based on professional principles and theories; viewed as an expert within the organization.
• Provides direction to assigned team(s)and to influence peers and team members appropriately including but not limited to delegate tasks to project teams or working group members to drive performance

Eligibility Requirements:

• Scientific background with a medico-scientific university degree
• Previous experience in drug safety or clinical research required
• REMS and/or RMP experience required
• Line management experience preferred
• 8-10 Years relevant experience with BA/ BS
• 6+ Years relevant experience with MA/ MS or MBA

Relevant experience consists of work in a scientific field or equivalent experience in association with R&D program teams and/or in cross-functional program management activities
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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 careers@gilead.com for assistance.

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

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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