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, with deep experience in vendor management and contracting to develop the global clinical outsourcing strategy. Acts as a key partner to clinical study teams, coordinating RFPs, bid defenses, and work orders/change orders.

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 RFPs, bid comparison analysis, managing bid defense meetings, and vendor scorecard development
• Identify service providers for clinical studies in collaboration with study management teams and clinical departments
• Collaborate with 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 contracts, including negotiation of costs
• Review change notification forms (CNFs) and Change Orders (COs) with contract manager and finance to ensure correct pricing
• Establish strong partnerships with clinical vendors to understand contracting challenges and develop simplified, 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 the vendor governance process with key clinical vendors, documenting decisions and ensuring governance compliance
• Work with study teams to establish KPI processes and 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 to build template site budgets using an FMV tool; negotiate budgets with clinical sites as needed
• Attend Study Execution Team (SET), monthly budget, and clinical meetings; present as needed
• Provide insight and feedback to the Clinical Operations Leadership Team
• Lead in clinical outsourcing process/tool development, improvement, and implementation

Qualifications

• Knowledge: BS or MS in a relevant discipline is 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, integrative thinker to establish outsourcing norms across the Clinical Department
• Knowledgeable of ongoing and new development clinical programs
• Excellent knowledge of the 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

• Experience: A minimum of 15+ years 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, and Scientific Collaborator engagement to conduct clinical trials
• Experience providing thought leadership and consistent customer service
• Expertise in the clinical contracting process (CDAs, SOW, FMV assessment, contract negotiations and management, Work Orders, Change Orders, Budget process)
• Demonstrated leadership skills in fast-paced and changing environments

• Attributes: Displays proactive acumen and inclusive engagement to drive decision making and timely delivery
• Influences cross-functional teams to adapt fit-for-purpose solutions to meet timelines
• Ability to analyze multiple complex sources (scientific, legal, financial, operational) and develop recommendations
• Excellent interpersonal, conflict management, and negotiation skills; ability to build key relationships
• Translates strategy into action with strong analytical and communication skills; orchestrates plans to resolve issues and mitigate risks
• Excellent negotiation/influence, grant/contract administration, written and oral communications

Skills

• Vendor management and contracting
• RFP development and vendor selection
• FMV analysis and budgeting
• Contract negotiation and management
• KPI development and vendor governance
• Clinical site contracts/CTAs
• Cross-functional collaboration with legal, finance, and study teams

Additional Requirements

• Travel approximately 10-15%
• Location: San Francisco or Cambridge based