Senior Director, Clinical Business Operations

Role Summary

Senior Director, Clinical Business Operations. Support the Clinical Department’s initiatives to contribute to the success of clinical trials, with a focus on vendor management and contracting to develop the global clinical outsourcing strategy. Partner with clinical study teams, coordinate RFPs and bid defenses, and negotiate work orders/change orders. Based in San Francisco or Cambridge with 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
• Identify service providers for clinical studies in collaboration with study management teams and clinical departments
• Coordinate with legal and financial groups on vendor contract and purchase order processes and negotiate terms as needed
• Work with clinical partners to build the Scope of Work (SOW) for contracts including cost negotiation
• 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 address contracting challenges with collaborative resolutions
• Drive the Fair Market Value (FMV) process with study teams and vendors to analyze and negotiate work orders and change orders
• Establish and manage vendor governance with key clinical vendors and document decisions and actions
• Develop KPI processes and standard clinical vendor KPIs to enhance oversight and performance
• Collaborate to establish template clinical site contracts/clinical trial agreements (CTAs)
• Build template site budgets using an FMV tool; negotiate budgets with clinical sites when needed
• Attend Study Execution Team (SET), monthly budget, and clinical meetings; present as needed
• Provide insight to the Clinical Operations Leadership Team
• Lead outsourcing process/tool development, improvement, and implementation

Qualifications

• 15+ years of experience in clinical research, biotech, and/or pharmaceutical industry
• Experience managing clinical outsourcing or procurement professionals
• Expertise in building RFPs and leading vendor selection
• 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 clinical contracting processes (CDAs, SOW, FMV, contract negotiations and management, Work Orders, COs, Budget)
• Demonstrated leadership in fast-paced, changing environments

Knowledge / Skills

• BS or MS in a relevant discipline
• In-depth knowledge of the clinical research process and regulatory environment
• Legal, financial, clinical operations, and regulatory acumen
• Contracting, negotiating, writing, benchmarking, and analytical skills
• Strategic thinker for Outsourcing norms across Clinical Department
• Knowledge of ongoing and new development clinical programs
• Understanding of costs of clinical procedures and data processing for estimating programs
• Proficiency with systems to manage contracting, finance, and invoicing

Education

• BS or MS in a relevant discipline

Additional Requirements

• Travel: approximately 10-15% (based in SF or Cambridge)