Senior Director, Clinical Business Operations

Role Summary

Senior Director, Clinical Business Operations. Based in San Francisco or Cambridge, with approximately 10-15% travel. Leads the clinical outsourcing strategy and vendor management to support clinical trials, reporting to the SVP of Clinical Operations.

Responsibilities

• Oversee communication with clinical vendors regarding contracts, scope of work, and budgets
• Lead the Request for Proposal (RFP) and vendor bidding process for clinical trials, including writing of RFP, bid comparison analysis, manage bid defense meetings, and vendor scorecard development
• Manage the identification of service providers for clinical studies in collaboration with the study management teams and clinical departments
• Liaise with the legal and financial groups on the vendor contract and purchase order process for the Clinical Department and negotiate terms of contract as needed
• Work with clinical department partners to build the Scope of Work (SOW) for the contract including negotiation of costs
• Review all change notification forms (CNFs) and Change Orders (COs) with contract manager and finance to ensure that correct pricing is established
• Liaise with the legal and financial groups on the vendor contract and purchase order process for the Clinical Department
• Establish strong partnerships with the clinical vendors to understand contracting challenges and develop simplified and collaborative resolutions to these challenges
• Drive the Fair Market Value (FMV) process through working with the study teams and vendors to analyze and negotiate the final work order and subsequent change orders
• Establish and manage the vendor governance process with key clinical vendors. Document key decisions and action plans and ensure compliance with the decisions established in governance meetings
• Work with study teams to establish KPI process and help establish standard clinical vendor KPIs to enhance vendor oversight and performance
• Collaborate with legal and clinical operations teams to establish template clinical site contracts/clinical trial agreements (CTAs)
• Interact with finance and clinical operations teams to build template site budget utilizing a FMV tool. In some studies, may help negotiate these budgets with clinical sites
• Attend Study Execution Team (SET), monthly budget, and clinical meetings; may present as needed
• Provide insight and feedback at Clinical Operations Leadership Team
• Lead in clinical outsourcing process/tool development, improvement, and implementation

Qualifications

• 15+ years of experience working in clinical research, biotech, and/or pharmaceutical company
• Experience managing clinical outsourcing or procurement professionals
• Expertise in building RFPs and leading the vendor selection process
• Strong experience in vendor and site CTA contracting/budgeting, FMV assessment, Scientific Collaborator engagement to conduct clinical trials
• Experience in providing thought leadership and consistent customer service
• Expertise in the clinical contracting process, including CDAs, SOW, FMV assessment, contract negotiations and management, Work Orders, Change Orders, and Budget process
• Demonstrated leadership skills in fast-paced and changing environments
• BS or MS in a relevant discipline is required

Skills

• Writing, critical analysis/evaluation, benchmarking, contracting, and negotiating
• Strategic and integrative thinking to establish outsourcing norms across the Clinical Department
• Knowledge of clinical development programs and regulatory environments
• Cost estimation and FMV tooling proficiency
• Strong interpersonal, negotiation, and relationship-building abilities

Education

• BS or MS in a relevant discipline

Additional Requirements

• Role based in San Francisco or Cambridge; some travel required (~10-15%)