Director, Standards & Collaborations Global Solicited Program
Director, Standards & Collaborations Global Solicited Program
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. Gileads 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 companys five core values. Thats 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 REMS, 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 Global PV solicited program oversight. We are seeking a PV expert to execute strategy and ensure operational excellence in the following areas:
- Developing and maintaining best practices to ensure compliance with global regulations as they relate to solicited programs required for the PSMF, inspection & audit readiness.
You will provide expertise to multiple stakeholders working closely with colleagues in Medical Affairs and Commercial and you will provide oversight of deliverables for these activities. The role would suit someone with strong communication skills and an ability to cope with a fast pace and moving targets, a broad PV and market research experience and an enthusiasm for understanding the business needs.
Core responsibilities include, but are not limited to the following:
- Develop / enhance strategic direction to provide innovative solutions to ensure compliance, quality and efficiency in support of Commercial and Medical Affairs solicited programs.
- Executing the global strategy, inclusive of understanding the commercial and regulatory plans, due diligence activities, onboarding and training of third-party vendors.
- Cross functional participation to support Gilead global initiatives involving patient safety
- Review of audit execution plans and audit responses as they pertain to solicited programs, PSMF and third-party vendors
- Responsible for performance evaluations; mentor junior staff to ensure competency in PV skills and knowledge.
- May recruit, hire, mentor, and manage direct reports, with responsibility for employee performance evaluations
- 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
- Demonstrates excellent verbal and written communication skills; has ability to provide direction to a team, and to influence peers and team members appropriately.
- 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
- Serves as consultant to GLPS management in area of expertise and acts as a spokesperson for the GLPS organization in matters pertaining to its policies, plans, and long-term goals and objectives.
- Reviews new regulatory requirements in area of responsibility, makes recommendations based on impact to existing processes and oversees implementation.
- Maintains knowledge of company disease and therapeutic areas
- Recognizes potential or impending problems, implements and delivers solutions.
- Contributes to strategic planning of S&C, SOP creation and updates for GLPS, review and critique audits and data analysis pertaining to their projects or the wider GLPS organization, manages corrective actions and highlights concerns to GLPS management
- Makes and effects decisions that are long-lasting and influence the future course of the GLPS organization. Decisions can affect the financial, employee, or public relations posture of the organization.
Education and Experience: At a minimum, the ideal candidate will possess
- Scientific background with a medico-scientific university degree
- Previous experience in multiple aspects of pharmacovigilance activities - several years and significant experience essential
- Experience with all sources (including social media) and end to end management of the various types of safety information
- Experience with the design & deployment of solicited programs including PAPs/PSPs, market research and HEOR.
- Project management experience preferred or experience in managing complex projects
- Performance management experience with direct reports
- Has an excellent knowledge and understanding of applicable regulatory requirements
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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 firstname.lastname@example.org 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. 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.\u200b
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