Director, Patient Safety Alliance & Vendor Management

Apply locations: United Kingdom - Cambridge
Time type: Full time
Posted on: Posted 26 Days Ago
Job requisition id: R

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination, and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed, and empowered to fulfill their aspirations. Join Gilead and help create possible, together.

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:

• 3rd party Due Diligence / Qualification: Lead Patient Safety input to operational due diligence/qualification activities and ensure effective communication and documentation.
• 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.
• Relationship and Stakeholder Management: Understand and communicate to PS stakeholders the nature of relationships in order to lead PS strategy and management for the relationship.
• Resource/Budget Management: Oversee assigned third party resource/budget and ensure efficient utilization, cost reduction and maximize productivity.
• Contract Management: Maintain strategic contracting approach and assess, write, negotiate and maintain contracts.
• Implementation: Maintain and lead training and education for Gilead stakeholders and assigned service parties.
• Performance Management: Partner with stakeholders to lead establishment and tracking of key indicators.
• Governance and Oversight: Collaborate with stakeholders to resolve/document compliance or quality issues.
• Regulatory Intelligence: Lead regulatory intelligence for assigned activities and sources of safety information.
• Innovation and Third-Party Related Systems Activities: Partner with the PS Systems team to lead vendor management for Systems innovation.
• Continuous Process/Tool Improvement: Anticipate internal and external business and regulatory needs/issues and recommend/lead implementation of solutions.
• People Management: (if assigned) Lead team of staff if assigned.

Job Skills:

• Identifies and pursues global and long-term goals for Gilead.
• Driver of change and innovation.
• Makes and effects decisions that are long-lasting and influence the future course of the PS organization.
• Solution Oriented: Develops solutions to a wide range of complex problems.
• Demonstrates excellent verbal and written communication skills.
• Serves as consultant to PS management in area of expertise.

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.
• PV agreement and or PS language for contracting experience.
• Project management experience preferred.
• Resource and workload management experience.
• 3rd party relationship management.
• Vendor Oversight and/or vendor management.
• Excellent knowledge and understanding of applicable regulatory requirements.
• Must have people and matrix management experience.

It is the policy of Gilead Sciences, Inc. to recruit select and employ the most qualified persons available for positions throughout the Company.