Associate Director, Outsourcing and Vendor Governance

About the role

The Associate Director, Outsourcing and Vendor Governance will lead the Vendor Governance function and support clinical outsourcing activities for current and future clinical trials. This position drives effective vendor governance while supporting Clinical Outsourcing activities, including vendor identification, request for proposal (RFP) processes, vendor selection, contract and budget negotiations, and 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 reports to the Senior Director, Outsourcing and Vendor Governance.

Responsibilities

• Clinical Outsourcing:
  • 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 and budget negotiation, and other related tasks for the full contract life cycle.
  • Negotiate vendor Master Service Agreements, commercial terms, and amendments.
  • Manage and negotiate all global clinical development contract agreements (work orders, change orders, confidentiality agreements, HCP agreements, subcontractor agreements, and amendments) in support of multiple functions (e.g., Clinical Operations, Regulatory, Clinical Supply, Data Management).
  • Guide project teams through the sourcing process and provide advice on best approaches and 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 internal staff questions regarding budget revisions and contract status.
  • Interact with suppliers on contract terms, resolve conflicts, and escalate issues as needed.
  • Partner with finance and study team members to address financial queries.
  • Create new contract provisions and templates, including modifications to existing templates in collaboration with internal stakeholders (e.g., Legal and impacted functional areas).
  • Demonstrate in-depth understanding of contractual provisions to lead contract review and negotiation through internal and external reviews, including:
    • Identify and manage contract risks.
    • Develop and ensure appropriate mitigation plans; communicate risks to stakeholders.
    • Analyze and provide solutions to leadership on complex contract or finance issues.
    • Ensure agreements comply with company requirements regarding risk assessment and liability.
    • Resolve complex contract and budget issues in collaboration with appropriate departments.
  • Master outsourcing systems in compliance with expectations, enter data in a timely manner, and serve as a subject matter expert for system-related questions.
  • Serve as subject matter expert for audits and support audit-readiness efforts.
  • Manage the purchase order process in support of Clinical Development stakeholders and functions.
  • Provide supervision, mentoring, and coaching to direct report(s).
• Vendor Governance:
  • Provide guidance and collaborate with Clinical Development stakeholders to ensure vendor governance standards, processes, and tools (e.g., KPIs, governance charters) are current, securing the required level of oversight in compliance with Arcus procedures.
  • Lead the vendor governance framework, activities, and initiatives, including the development of process documents and tools.
  • Drive governance meetings, ensuring proactive scheduling, appropriate attendees, clear delineation of roles and responsibilities, and meaningful meeting content.
  • Facilitate governance meeting preparation and 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 mitigate vendor relationship-level risks.
  • Address escalations on vendor performance issues and propose innovative solutions to reduce risks and achieve satisfactory outcomes.
  • Seek innovative solutions (technology or process) to advance how Arcus engages vendors.
  • Communicate vendor developments (e.g., acquisitions, innovative technology, restructure) to Arcus stakeholders.
• Process Improvement:
  • Partner with Clinical Development functional leads on developing optimized category/function sourcing strategy, sourcing model, and strengthen relationships with selected, qualified vendors.
  • Lead OVG initiatives and department activities (e.g., process refinement, financial analyses, metrics and key performance indicators, spend consolidation, performance productivity, cycle time reduction, audit readiness).
  • Prepare presentations and train resources and providers on core business requirements.

Qualifications

• B.A./B.S. required; MBA preferred.
• 10+ years of related business/industry experience.
• Experience in clinical outsourcing in pharmaceutical, biotech, academia, or CROs (Clinical Research Organizations).
• Experience in vendor selection (including RFI/RFP process), contracting, and budget negotiation.
• Direct or indirect management of vendor governance meetings and processes.
• Experience managing direct reports is preferred but not required.

Skills

• In-depth understanding of outsourcing activities for Phase I to III clinical trials, audit preparedness, and related good business practices.
• Expert knowledge of pharmaceutical sourcing/procurement processes, sourcing models, vendor relationship management, governance, and oversight principles.
• Insight into the current clinical vendor landscape across different vendor service categories.
• Strong financial acumen.
• Initiative-taker with minimal supervision; high self-motivation and ability to work and plan independently as well as in a team environment (virtual or in-person).
• Ability to work with cross-functional team members and facilitate communication with internal/external stakeholders.
• Excellent organizational and time management skills to accomplish multiple tasks efficiently and effectively in a demanding environment.
• Diligent and detail-focused with the ability to expedite quick turn-around.
• Critical thinking, ability to analyze and synthesize information to understand issues, identify alternate options, and support sound decision-making.
• Excellent computer skills, including advanced knowledge of MS Excel, Word, PowerPoint, and Outlook.
• Strong verbal and written communication skills.
• Ability to execute time-sensitive matters while maintaining accuracy and confidentiality.
• High degree of professionalism, punctuality, and ability to deliver commitments on-time.
• Sound business judgment and proactive, independent work style.
• Technical aptitude and result-driven approach.
• Exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results.
• Ability to travel, including overnight stays.

Location

This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote-based.

Pay

The anticipated salary range for fully qualified candidates applying for this position is $195,000 - $205,000 USD annually. The actual salary may vary based on factors including individual education, experience, tenure, skills and abilities, internal equity, and alignment with market data.

Benefits

In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here.

Physical Requirements

• Office setting: Must possess mobility to work in a standard office setting and use standard office equipment, including a computer.
• Vision to read printed materials and a computer screen; hearing and speech to communicate in person, before groups, and over the telephone.
• Primarily a sedentary office classification, though standing in work areas and walking between work areas may be required.
• Finger dexterity needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment.
• Occasional bending, stooping, kneeling, reaching, pushing, and pulling drawers open and closed to retrieve and file information.
• Ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.