We are seeking an experienced Director of Clinical Business Operations & Strategic Vendor Management to lead outsourcing strategy, vendor governance, and business operations across Phase 2 and Phase 3 clinical development programs. This role will partner closely with Clinical Operations, Finance, Legal, Quality, and other cross-functional teams to ensure efficient study execution through effective vendor selection, contracting, oversight, and financial management.
Key Responsibilities:
Develop and execute clinical sourcing and outsourcing strategies supporting global Phase 2 and Phase 3 studies.
Lead vendor selection processes, including RFPs, bid evaluations, due diligence, and contract negotiations.
Manage strategic relationships with CROs and clinical service providers, ensuring performance, quality, and delivery expectations are met.
Establish and oversee vendor governance, performance metrics, risk management, and escalation processes.
Partner with Clinical Operations and Finance to develop, monitor, and forecast clinical trial budgets.
Lead contract management activities, including MSAs, SOWs, change orders, and financial oversight.
Drive process improvements, operational excellence, and scalable vendor management practices.
Provide strategic guidance on outsourcing models, resource planning, and vendor engagement strategies.
Qualifications:
Bachelor's degree in Life Sciences, Business, or related field; advanced degree preferred.
10+ years of experience in biotech, pharmaceutical, or clinical research environments.
Significant experience supporting Phase 2 and Phase 3 clinical trials.
Proven expertise in clinical outsourcing, vendor management, strategic sourcing, and contract negotiations.
Strong financial acumen with experience managing clinical trial budgets and forecasts.
Excellent leadership, stakeholder management, communication, and problem-solving skills.
This is an opportunity to play a key leadership role in advancing clinical development programs by building strategic partnerships, optimizing operations, and driving successful study execution.
Numbers & Facts
Location
California
Website
https://www.enigmarecruiters.com
Skills
Alliance/Partner Managementunmatched
Bid Analysisunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Budget Managementunmatched
Budgetingunmatched
Business Operationsunmatched
Business Strategyunmatched
Change Requests/Ordersunmatched
Clinical Monitoringunmatched
Clinical Researchunmatched
Clinical Trialunmatched
Clinical Trial Managementunmatched
Contract Managementunmatched
Contract Negotiationunmatched
Contract Research Organization (CRO)unmatched
Cross-Functionalunmatched
Drug Developmentunmatched
Due Diligenceunmatched
Financeunmatched
Financial Managementunmatched
Forecastingunmatched
Leadershipunmatched
Legalunmatched
Operational Improvementunmatched
Outsourcingunmatched
Performance Metricsunmatched
Phase III Clinical Trialsunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Relationship Managementunmatched
Risk Managementunmatched
Sourcing Strategyunmatched
Statement of Work (SOW)unmatched
Vendor/Supplier Evaluationunmatched
Vendor/Supplier Managementunmatched
Vendor/Supplier Planningunmatched
Vendor/Supplier Selectionunmatched
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