Sr Director, Safety Alliance Management & Agreements
Sr Director, Safety Alliance Management & Agreements
United States - North Carolina - Durham
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 Senior Director responsible for PV Alliance management and PV Agreements. This is a small team, with a truly global remit and we are seeking a PV expert to set strategy, vision and ensure operational excellence in the following areas:
- Developing and maintaining PV Agreements for License Partners, Clinical Collaborations, Co-Commercialization, Distributors, CROs, Divestments
- Onboarding and oversight of Distributors across the globe who perform PV activities on behalf of Gilead
As head of PV Alliance and PVAs you will provide expertise to multiple stakeholders and to complex alliances and collaborations with products in different stages of development working closely with colleagues in Regulatory Affairs, Clinical, GLPS, Alliance Management 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 PV agreement experience and an enthusiasm for understanding the business needs, leveraging the skill set of the existing team and making a difference.
Core responsibilities include, but are not limited to the following:
- Setting the global strategy for PVAs ensuring compliance with global regulations
- Setting the global strategy for Distributor PV, inclusive of understanding the commercial and regulatory plans, due diligence activities, onboarding and training of global Distributors
- Providing expertise into all PV alliances inclusive of divestments, clinical and commercial collaborations
- Review of audit execution plans and audit responses as they pertain to Distributors and Partners
- Working closely with the Head of PV Affiliate Excellence to ensure oversight and implementation of the global strategy for Solicited Programs in Gilead affiliates worldwide
- Being a core member of the S&C Leadership Team
- May represent S&C as a member of the GLPS Extended Leadership Team to ensure input into operational decisions impacting the GLPS department
- 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
- May recruit, hire, mentor, and manage direct reports, with responsibility for employee performance evaluations; mentors junior staff to ensure competence in pharmacovigilance skills and knowledge; translates overall direction and strategy, communicates across organizational levels and functions; interprets and executes policies and procedures, and provides direction based on general policies and management guidance.
- Able to gather information or assign tasks or activities for one or more projects to manage competing priority jobs, and delegates special projects to junior staff if applicable and as needed.
- 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
- PV agreement experience
- Project management experience preferred or experience in managing complex projects
- Has an excellent knowledge and understanding of applicable regulatory requirements
- Line management experience preferred
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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.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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