Agenus

Director, Vendor Management

US-MA-Lexington
Job ID
2017-1253
Category
Development

Overview

Job Summary: The Vendor Management group sits within the Global Clinical Operations group with the primary responsibility of maximizing the value of the relationships between Agenus and the Strategic CRO and vendor sourcing partners supporting the portfolio (Phase I-IV). The intent is for that value to be translated into improved business terms, increased productivity, reliable quality, strategic innovation, and enhanced working relationships. The Director is expected to collaborate with key internal and external stakeholders, at a departmental and a cross-department with Global Clinical Operations level to ensure Agenus vendors perform to the highest level.

Hierarchal Position the Director of Vendor Management will report directly to the Executive Director of Global Clinical Operations and is tasked with the following overarching responsibilities:

• Partner with Clinical Operations Finance and relevant functions to provide leadership and direction on strategic sourcing and associated operating models.
• Build an understanding of the assigned departmental vendors, their organization and capabilities to anticipate opportunities & risks with those vendors.
• Implement effective governance and assist departments to build strong relationships to maximize performance and value delivered by CROs and other vendors
• Create a culture of joint accountability and enhanced partnering skills within Agenus to ensure CRO / third party vendors’ performance
• Facilitate efficient and collaborative resolution of problems and conflicts with CRO and on behalf of CROs within Global Clinical Operations.

Responsibilities

Primary Responsibilities:

  • CRO Alliance Management Subject Matter Expert
  • Sourcing Strategy/Vendor Selection
  • Establishing preferred standardized pricing, service level agreements, and governance
  • Process Improvement and risk management
  • Responsible for collecting and addressing third party vendor performance data and metrics

 

Additional Responsibilities:

 

  • Driving vendor identification, strategy, management and oversight practices across the Global Clinical Operations organization.
  • Piloting an effective global outsourcing strategy for the broader clinical and pre-clinical relationships.
  • Ensure vendor partnership health, compliance and structures exist through implementation of standard frameworks of governance, metrics, escalation and functional oversight.
  • Partnership with the business, lead strategies for optimizing Clinical Development and Global Clinical Operations performance through external capabilities
  • Provide vendor processes and procedures training to all Global Clinical Operations (and any additional related departments as needed) personnel,
  • Work cross functionally with Clinical Teams, Finance, Legal and QA towards solution, process, vendor qualifications and communication improvements.

 

Vendor Performance Management

  • Responsible for portfolio-level identification of trends, quality management, and risk mitigation, including receiving KPI reports and audit reports.
  • Proactively address issues and risks escalated from the functions and guide the vendor toward improvement.
  • Collaborate with vendor process development and implementation
  • Utilizes rigorous processes, procedures, and tools to ensure financial discipline and transparency in vendor spend, assists with financial and resource projections across clinical projects and studies, manages the development, negotiation and execution of vendor contracts, as well as facilitates effective vendor oversight.
  • Lead vendor on-boarding activities.
  • Generate and maintain vendor management central file documents and ensure central file is “inspection ready” at all times and document Agenus Sponsor oversight
  • Provides alignment between the vendor and clinical team on expected deliverables and quality.
  • Work closely with vendors to help them understand and adopt Agenus governance processes and materials.
  • Monitor vendor KPIs.
  • Develop tools for assessing vendor performance.
  • Conduct vendor performance assessment (VPA) and share outcomes with Global Clinical Operations and related teams, and provide recommendations to improve the relationship.

Vendor Relationship Management

  • Act as point of escalation for issue resolution, including performance, compliance, and financial issues to ensure the study stays on track and on budget.
  • Maintain awareness of vendor status, trends, and high-level risks through regular communication with vendor counterpart.
  • Assist the vendor in connecting with key stakeholders and other divisions to help build vendor’s portfolio and ensure success across Agenus
  • Attend clinical study team meetings and other Global Clinical Operations forums as required.

Qualifications

Competencies

Individuals in the Director position are expected to demonstrate advanced core competence in the areas of communication, planning and prioritization, teamwork and proactivity. This includes:

  • an ability to distil and articulate complex issues to a wide range of audience types
  • proactively identifying opportunities for operating more efficiently.

The Director also demonstrates foundational leadership skills by motivating teams, and helping them clarify goals, tasks and responsibilities.

In addition, the Director must have established an advanced understanding of Drug Development and Study Design, as well as and Vendor Performance and Quality Management. This includes the application of GCP principles to vendor performance and an ability to resolve escalated vendor issues.

 

 

Education and Experience

  • BA/BS. Experience in lieu of education considered.
  • Clinical Operations, Project Management, Clinical Outsourcing, and/or Service Provider management experience required. Process Improvement, Change Management, Clinical Quality Management experience is a plus.
  • At least 10 years’ experience in a pharmaceutical or CRO (drug development) environment with knowledge of all stages of drug development, clinical operations, clinical outsourcing, and Good Clinical Practice.
  • At least 2 years’ of clinical trials vendor management experience

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