Associate Director, Supplier Governance

4 months ago

Abingdon, United Kingdom Adaptimmune Full time

**Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.**

**Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.**

**PRIMARY RESPONSIBILITY**

This role exists to execute global oversight and management of a category or categories of external regulated service providers within Clinical Development.

Partnering closely with Clinical Development teams, Compliance & Procurement, the role ensures quality and compliance in supplier evaluation and selection, negotiates and manages outsourced statements of work and budgets and executes ongoing supplier oversight including active issue management and the development and deployment of performance metrics.

This role will may also support process improvement, innovation and operational efficiency project workstreams as required.

**KEY RESPONSIBILITIES**
- Execution of Supplier Governance capabilities across defined Suppliers or Supplier Categories
- Implement governance and/or functional oversight plans & processes to ensure appropriate Supplier oversight per ICH E6 & other regulatory guidance for defined Suppliers
- Identification, evaluation and selection of Clinical Development suppliers such as clinical CROs, data management, biostatistics, central labs, IRT, Imaging, ePRO, biomarkers etc.
- Lead vendor qualification and third party risk management
- Contract lifecycle management through coordination of change orders including active negotiation of scope of work, payment terms and budgets
- Measurement of Supplier performance utilizing Scorecard/Metrics; and communicating feedback to the supplier, encourage adaptation on best practices across supplier types and development of continuous process improvements
- Execute relationship management strategy
- Leading supplier governance meetings (typically up to Senior Director level) and operating reviews including issue management
- Identification/monitoring of current trends in outsourcing practices in the industry and specific to regions where Adaptimmune has interest in developing capabilities
- Support and execute process, training & change management activities Support development of Supplier Governance and Clinical Planning process development and drive continuous improvement
- Ensure audit readiness and
- Clinical Operations Planning
- Budget management: provide information as requested to support clinical budget management coordination
- Develop tools and process to track vendor spend
- Support other activities as requested by line management

**QUALIFICATIONS & EXPERIENCE**

**Required**
- Minimum of Bachelor’s degree in Science or Business discipline or qualified by experience
- Previous experience in a matrix environment
- Experience working with Clinical Operations teams in pharmaceutical, CRO, or biotechnology companies including proven experience of:Negotiation of contracts/CRO budgets independently, Development and monitoring of metrics & KPIs, Development and execution of supplier governance of related processes including resolution/ escalation of issues relating to supplier performance
- Knowledge of ICH/GCP and FDA regulations

**OTHER REQUIREMENTS**
- Global travel 2-3 times per year or as needed
- Valid driver's license
- Ability to travel internationally (valid passport).

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