Associate Director, Outsourcing and Vendor Governance

Summary The Associate Director, Outsourcing and Vendor Governance will play a key role in leading the Vendor Governance function and supporting clinical outsourcing activities for current and future clinical trials. This position is responsible for driving effective vendor governance while also supporting Clinical Outsourcing activities including vendor identification, request for proposal (RFP) processes, vendor selection, contract and budget negotiations, and sound financial stewardship.

The role partners closely with Clinical Development teams, Legal, Finance, and other internal stakeholders to address vendor relationship, contract, and business-related matters. This role involves mentoring and managing direct reports and will report to the Senior Director, Outsourcing and Vendor Governance.

Description Summary The  Associate Director, Outsourcing and Vendor Governance will play a key role in leading the Vendor Governance function and supporting clinical outsourcing activities for current and future clinical trials. This position is responsible for driving effective vendor governance while also supporting Clinical Outsourcing activities including vendor identification, request for proposal (RFP) processes, vendor selection, contract and budget negotiations, and sound financial stewardship.

The role partners closely with Clinical Development teams, Legal, Finance, and other internal stakeholders to address vendor relationship, contract, and business-related matters. This role involves mentoring and managing direct reports and will report to the Senior Director, Outsourcing and Vendor Governance.

Responsibilities

• Independently manage outsourcing activities for Phase I to III clinical trials and Clinical Development functional area projects, including vendor capability assessments, RFP/RFI, selection, contract & budget negotiation, and other related tasks for the full contract life cycle, as follows:
  • Negotiate vendor Master Service Agreements, commercial terms, and amendments.
  • Responsible for management and negotiation of all global clinical development contract agreements (Work orders, change orders, confidentiality, HCP agreements, subcontractor agreements, and amendments thereto) in support of multiple functions (e.g., Clinical Operations, Regulatory, Clinical Supply, Data Management, etc.).
  • Guide project teams through the sourcing process and give appropriate suggestions and advice on the best approach/industry practices.
  • Partner with study team members to manage supplier bidding and proposal development (RFP creation and bid analysis). Facilitate and manage supplier bid defense meetings and associated follow-up.
  • Lead contract-related communication with clinical vendors. Respond to questions from internal staff regarding budget revisions and contract status. Interact with suppliers on contract terms. Appropriately resolve conflicts and elevate issues.
  • Partner with finance and study team members to address financial queries.
  • Create new contract provisions and templates, including modification to existing templates in collaboration with internal stakeholders (e.g., Legal and impacted functional area)
• Demonstrate expanded understanding of contractual provision terms to lead contract review and negotiation through internal and external reviews, as follows:
  • Identify and manage contract risks. Develops and ensures appropriate mitigation plans risks are communicated to stakeholders.
  • Analyze, provide information, and solutions to leadership on complex contract or finance issues.
  • Ensure agreements comply with company requirements regarding risk assessment and liability.
• Respond to and resolve complex contract and budget issues in collaboration with appropriate department(s) representatives.
• Master outsourcing systems in compliance with expectations, enter data in a timely manner, and serve as subject matter expert to peers and colleagues for system related questions.
• Serve as subject matter expert for audits and support audit-readiness efforts.
• Manage purchase order process in support of Clinical Development stakeholders and functions.
• Provide supervision, mentoring, and coaching to direct report(s).

• Provide guidance and collaborate with Clinical Development stakeholders to ensure that all relevant vendor governance standards, processes, and tools (e.g., KPIs, governance charters, etc.) current, securing the required level of Arcus oversight, in compliance with Arcus procedures and requirements.
• Provide and lead vendor governance framework, activities, and initiatives, including the development of process documents and tools.
• Drive governance meetings, ensure proactive scheduling, appropriate attendees, clear delineation of roles and responsibilities, and meaningful meeting content.
• Facilitate governance meeting preparation and perform follow-up while maintaining proper tracking and archival of materials in a central repository.
• Collaborate with vendor counterparts and Arcus stakeholders to identify, document, and…