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Director, Standards & Collaborations Global Solicited Program

Employer
GILEAD Sciences
Location
San Mateo County, CA
Closing date
Sep 26, 2021

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Sector
Other
Organization Type
Corporate
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.Job DescriptionThe 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 responsibilitiesStandards 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 safetyReview of audit execution plans and audit responses as they pertain to solicited programs, PSMF and third-party vendorsResponsible 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 evaluationsJob Skills: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 organizationDemonstrates 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 organizationServes 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 areasRecognizes 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 managementMakes 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 possessScientific background with a medico-scientific university degreePrevious experience in multiple aspects of pharmacovigilance activities - several years and significant experience essentialExperience 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 projectsPerformance management experience with direct reportsHas an excellent knowledge and understanding of applicable regulatory requirementsFor jobs in the United States: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.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.For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.
Full time

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