Third Party Patient Safety Director
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
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The Patient Safety (PS) department is a global function that is part of the Development organization within Gilead. The main Pharmacovigilance activities of PS are centered at three sites: Foster City and Santa Monica in the USA and Cambridge in the UK.
This role sits at Foster City in the PS Strategic Operations team responsible for review of PV-related policies and global regulations, PS Alliances and Vendor management, Operational support of clinical studies, Audit and inspection readiness/support, Training, and ICSR Excellence.
This role is part of the PS Alliances and Vendor Management Team, sitting in the team that leads PS alliances with partners, distributors and services providers (including due diligence, PS strategy for partnership/service provision, contracting, PS agreements and PS language in contracts, relationship management, compliance oversight).
We are seeking a PS expert to lead and support the execution of strategy and ensure operational excellence in the following areas:
- Lead strategic PS outsourcing for all clinical trial activity (includes strategy for outsourcing to clinical trial CROs and other PS business partners)
- Liaison with key clinical trial key stakeholders for 3rd party activity, including (not limited to) Clinical Operations, Vendor Outsourcing and QMG Vendor leads as well as PS representative on CRO related governance committees.
- Maintain strategic contracting approach (incudes consideration for MSA and Safety contracting as well as CRO safety management plans) and ensure alignment with protocol
- Ensure PS requirements for other sources of clinical trial related activities with third parties are addressed: e.g., digital activities with patients and patient groups, clinical trial supply
- Lead the strategy for PS oversight of clinical trial outsourced activities, contracting and issues management (including VIMS)
- Foster City site-based leader for Strategic Operations PS Alliances Organization: in addition to the above responsibilities act as a team lead for the Foster City site, including but not limited to coordinating and meeting with key stakeholders that are primarily at FC (e.g. Business Development, Alliance Management and Vendor Oversight).
Expectations for the above activities includes understanding of the Gilead sponsored clinical trial processes or at a minimum understanding of clinical trial processes, the nature of the contracting, PS strategy for contracting, operations due diligence, developing and maintaining PS Agreements or supporting PS language in contracts, supporting compliance with agreements, or contracting through oversight and in audits/inspections, focus is on solution-oriented relationship management.
You will provide expertise to multiple stakeholders working closely with colleagues in Development Vendor Operations, Clinical Development/Operations, Business Development, Alliance Management, Legal, Patient Safety, Regulatory Affairs, Medical Affairs, and Commercial. The role will suit someone with strong strategic thinking, communication, negotiation, facilitation, project management, presentation and analytical skills with an ability to excel in a fast-paced environment with moving targets. A broad PS and PS agreement/contracting experience is preferred and an enthusiasm for understanding the business needs and strong internal and external relationship management.
Core responsibilities include, but are not limited to the following:
- Lead strategy for 3rd party PS activities in Clinical Trials
- Lead or support lead for operational due diligence of 3rd party PV system
- Creating and maintaining 3rd party PV Agreements and/or PS contracting
- Develop or support development of a strategy and maintaining processes for oversight of compliance with contracts
- Business lead or support lead for 3rd party Audits and global regulatory inspections.
- Foster City PS Strategic Operations Alliances and VM site based leader
- May participate in budget planning and management.
Education and Experience: At a minimum, the ideal candidate will possess
- Identifies and pursues global and long-term goals for Gilead, the department, the group, in collaboration with team, considering and providing support for the strategic goals of the organization
- Demonstrates excellent verbal and written communication skills; has ability to provide direction to a matrix 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 PS management in area of expertise and acts as a spokesperson for the PS 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 department strategic planning, SOP creation and updates for PS, review and critique audits and data analysis pertaining to their projects or the wider PS organization, manages corrective actions and highlights concerns to PS management
- Makes and effects decisions that are long-lasting and influence the future course of the PS organization. Decisions can affect the financial, employee, or public relations posture of the organization.
- Scientific background with a medico-scientific university degree
- Previous experience in multiple aspects of pharmacovigilance activities - several years and significant experience essential
- PV agreement and or PS language for contracting experience
- Project management experience preferred or experience in managing complex projects
- Resource and workload management experience
- 3rd party relationship management
- Vendor Oversight and / or vendor management
- Has an excellent knowledge and understanding of applicable regulatory requirements
The salary range for this position is: $214,795.00 - $277,970.00. 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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