Associate Director, Outsourcing and Vendor Governance
This role leads the Vendor Governance function and supports clinical outsourcing activities for current and future clinical trials. The position drives effective vendor governance while managing clinical outsourcing processes, including vendor identification, RFP processes, vendor selection, contract and budget negotiations, and financial stewardship. The Associate Director partners closely with Clinical Development teams, Legal, Finance, and other internal stakeholders to address vendor relationship, contract, and business-related matters, and mentors direct reports.
Responsibilities
- Clinical Outsourcing
- Independently manage outsourcing activities for Phase I to III clinical trials and Clinical Development projects, including vendor capability assessments, RFP/RFI processes, selection, contract and budget negotiation, and full contract lifecycle management.
- Negotiate vendor Master Service Agreements, commercial terms, and amendments.
- Manage and negotiate global clinical development contract agreements (work orders, change orders, confidentiality agreements, HCP agreements, subcontractor agreements, and amendments) supporting multiple functions (e.g., Clinical Operations, Regulatory, Clinical Supply, Data Management).
- Guide project teams through the sourcing process, providing advice on best approaches and industry practices.
- Partner with study teams to manage supplier bidding and proposal development (RFP creation and bid analysis).
- Facilitate and manage supplier bid defense meetings and follow-up.
- Lead contract-related communication with clinical vendors and resolve conflicts or escalate issues as needed.
- Respond to internal staff questions regarding budget revisions and contract status.
- Interact with suppliers on contract terms and address financial queries in collaboration with Finance and study teams.
- Create and modify contract provisions and templates in collaboration with Legal and other stakeholders.
- Identify, manage, and mitigate contract risks, ensuring risks are communicated to stakeholders.
- Analyze and provide solutions to leadership on complex contract or finance issues.
- Ensure agreements comply with company requirements for risk assessment and liability.
- Resolve complex contract and budget issues in collaboration with relevant departments.
- Master outsourcing systems, ensure timely data entry, and serve as a subject matter expert for system-related questions.
- Serve as a subject matter expert for audits and support audit-readiness efforts.
- Manage the purchase order process for Clinical Development stakeholders.
- 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 and compliant with Arcus procedures.
- Lead the vendor governance framework, activities, and initiatives, including development of process documents and tools.
- Drive governance meetings, ensuring proactive scheduling, appropriate attendees, clear roles and responsibilities, and meaningful content.
- Facilitate governance meeting preparation, follow-up, and maintain proper tracking and archival of materials.
- Collaborate with vendor counterparts and Arcus stakeholders to identify, document, and mitigate vendor relationship 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 vendor engagement.
- Communicate vendor developments (e.g., acquisitions, innovative technology, restructures) to Arcus stakeholders.
- Process Improvement
- Partner with Clinical Development functional leads to develop optimized category/function sourcing strategies and strengthen relationships with selected vendors.
- Lead Outsourcing and Vendor Governance (OVG) initiatives and department activities (e.g., process refinement, financial analyses, metrics, spend consolidation, performance productivity, cycle time reduction, audit readiness).
- Prepare presentations and train resources and providers on core business requirements.
Requirements
- A B.A./B.S. is required; MBA is preferred.
- 10+ years of related business/industry experience.
- Experience in clinical outsourcing within pharmaceutical, biotech, academia, or CROs (Clinical Research Organizations).
- Experience in vendor selection (including RFI/RFP processes), 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 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 service categories.
- Strong financial acumen.
- Ability to take initiative with minimal supervision, work independently, and plan effectively.
- Excellent organizational and time management skills to handle multiple tasks efficiently in a demanding environment.
- Diligent, detail-focused, and capable of expediting quick turnaround.
- Critical thinking and ability to analyze and synthesize information to support sound decision-making.
- Advanced computer skills, including 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 positive interactions with others.
- Sound business judgment and proactive, independent work style.
- Technical aptitude and results-driven mindset.
- Ability to exercise independent judgment in methods, techniques, and evaluation criteria.
- Willingness to travel, including overnight stays.
Benefits
In addition to a competitive market-based salary, Arcus offers participation in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about total rewards can be found here.
Pay
The anticipated salary range for fully qualified candidates is $195,000 - $205,000 USD annually. The actual salary may vary based on factors such as education, experience, tenure, skills, internal equity, and market alignment.
Schedule
This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote-based.
Physical Requirements
- Primarily a sedentary office role, though standing and walking between work areas may be required.
- Finger dexterity needed for computer use and operating standard office equipment.
- Occasional bending, stooping, kneeling, reaching, pushing, and pulling to retrieve and file information.
- Ability to lift, carry, push, or pull materials and objects weighing up to 25 pounds.