Director, Patient Safety Alliance

Job Description

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 based in Cambridge, UK is part of 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 that is charged with evolving and maintaining best in class patient safety third party, sources of safety information and resourcing capability (including strategy, process, systems, resources). Third parties include not limited to business/licensing/integration/co-development/co-marketing partners, distributors, and services providers. Sources of safety information include not limited to market research, social listening, digital platforms, patient assistance and support programs, specialty pharmacies, manufacturing and supply, health outcomes studies, investigator sponsor study, government organizations, finance / rebate programs, medical and commercial field.

We are seeking a pharmacovigilance and third-party expert, and strategic business partner to lead and support the execution of strategy and ensure operational excellence in the following areas of third-party activity and managing sources of safety information.

Core responsibilities include, but are not limited to the following:

1. 3rd party Due Diligence / Qualification: Lead Patient Safety input to operational due diligence/qualification activities and ensure effective communication and documentation.
2. Patient Safety strategy for third party activity: Understand strategic approach across all assigned types of third-party activity and sources of safety information, develop and maintain strategy for the various types that is rooted in compliance with global regulations and driving efficient and effective patient safety activities for Gilead. Organize and conduct strategy meeting with internal stakeholders to gather input and alignment for strategy and to update and maintain strategy throughout life of relationship. Maintain documentation of strategy with rationale and considerations throughout third-party relationship.
3. Relationship and Stakeholder Management: Understand and communicate to PS stakeholders nature of relationship or type of relationships in order to lead PS strategy and management for the relationship. Understand and know when and how to proactively engage with stakeholders. Organize, conduct meetings and lead negotiation with Gilead stakeholders and external third parties.
4. Resource/Budget Management: Oversee assigned third party resource /budget and ensure efficient utilization, cost reduction and maximize productivity.
5. Contract Management: Maintain strategic contracting approach (includes consideration for MSA, Work Order and Safety contracting). Maintain assigned patient safety language for contracts and safety agreement templates (e.g. PVA, SDEA). Assess, Write, negotiate and maintain contracts and/or oversee vendor involvement in safety contracting.
6. Implementation: Maintain and lead training and education for Gilead stakeholders and assigned service parties, Ensure effective mechanism implemented and monitored relevant third party safety activities, including but not limited to collection safety info, provision of aggregate reports, and submissions.
7. Performance Management: Partner with stakeholders to lead establishment and tracking of key indicators.
8. Governance and Oversight: Collaborate with stakeholders to resolve/document compliance or quality issues. Establish and utilize escalation pathways within Gilead and third parties to drive third party performance. Implement and oversee management monitoring, risk assessment and mitigation strategies for assigned third party(ies).
9. Regulatory Intelligence: Lead regulatory intelligence for assigned activities and or sources of safety information, includes knowledge of new and updated regulations and lead or input into Gilead interpretation of regulations, and provide recommendation on impact to existing processes and oversees related implementations.
10. Innovation and Third-Party Related Systems Activities: Partner with the PS Systems team to lead vendor management for Systems innovation and systems related third party activity.
11. Continuous Process/Tool Improvement: Anticipate internal and external business and regulatory needs/issues and recommend/lead implementation of solutions/process/tool improvements.
12. People Management: (if assigned) Lead team of staff if assigned. People management to include matrix working and direct line leadership.

Job Skills:

1. 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. Maintains knowledge of company disease and therapeutic areas.
2. Driver of change and innovation: 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.
3. 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.
4. Solution Oriented: 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. Recognizes potential or impending problems, implements, and delivers solutions.
5. Demonstrates excellent verbal and written communication skills; has ability to provide direction to a matrix team, and to influence peers and team members appropriately. Formidable negotiation skills.
6. 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.

Education and Experience: At a minimum, the ideal candidate will possess:

1. Scientific background with a medico-scientific university degree.
2. Previous experience in multiple aspects of pharmacovigilance activities - several years and significant experience essential.
3. PV agreement and or PS language for contracting experience.
4. Project management experience preferred or experience in managing complex projects.
5. Resource and workload management experience.
6. 3rd party relationship management.
7. Vendor Oversight and / or vendor management.
8. Has an excellent knowledge and understanding of applicable regulatory requirements.
9. Sr Director must have people and matrix management experience.