Senior Director, Clinical Business Operations

Role Summary

Senior Director of Clinical Business Operations, reporting to the SVP of Clinical Operations. Supports the Clinical Department’s initiatives to contribute to the success of clinical trials. Develops global clinical outsourcing strategy with a focus on vendor management and contracting. Partners with clinical study teams to select service providers, manage RFPs and bid defenses, and negotiate work orders/change orders. Based in San Francisco or Cambridge with approximately 10-15% travel.

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 identification of service providers for clinical studies in collaboration with study management teams and clinical departments
• Liaise with legal and financial groups on 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 correct pricing
• Liaise with legal and financial groups on the vendor contract and purchase order process for the Clinical Department
• Establish strong partnerships with clinical vendors to understand contracting challenges and develop simplified and collaborative resolutions
• Drive the Fair Market Value (FMV) process with study teams and vendors to analyze and negotiate final work orders and subsequent change orders
• Establish and manage vendor governance with key clinical vendors; document decisions and ensure compliance
• Work with study teams to establish KPI processes and standard clinical vendor KPIs to enhance oversight and performance
• Collaborate with legal and clinical operations teams to establish template clinical site contracts/CTAs
• Interact with finance and clinical operations to build template site budgets using FMV tools; may help negotiate 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

• BS or MS in a relevant discipline (required)
• In-depth knowledge of the clinical research process and regulatory environment across functions
• Legal, financial, clinical operations, and regulatory acumen
• Strong skills in writing, critical analysis/evaluation, benchmarking, contracting, and negotiating
• Strategic and integrative thinker to establish outsourcing norms across the Clinical Department
• Knowledge of ongoing and new development clinical programs
• Extensive knowledge of costs of clinical procedures and data processing for estimating clinical programs
• Strong skills in computer systems and software to manage contracting, finance, and invoice processing
• Minimum of 15+ years of experience in clinical research, biotech, 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, and engagement to conduct clinical trials
• Experience providing thought leadership and consistent customer service
• Expertise in the clinical contracting process (CDAs, SOW, FMV, contract negotiations/management, Work Orders, COs, Budget process)
• Demonstrated leadership skills in fast-paced, changing environments
• Proactive, inclusive engagement to drive decision making and efficiency
• Ability to analyze multiple complex sources (scientific, legal, financial, operational) and develop recommendations
• Excellent interpersonal, conflict management, and negotiation skills; strong stakeholder relationship-building
• Ability to translate strategy into action and communicate complex issues clearly
• Excellent negotiation/influence, contract administration, and written/oral communications skills

Education

• BS or MS in a relevant discipline (required)