Senior Director, Clinical Business Operations

Role Summary

Senior Director, Clinical Business Operations responsible for developing and managing the global clinical outsourcing strategy, vendor management, contracting, and related operations to support clinical trials. 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
• 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 processes and negotiate terms as needed
• Work with clinical department partners to build the Scope of Work (SOW) for contracts including cost negotiation
• Review CNFs and COs with contract manager and finance to ensure correct pricing
• Establish strong partnerships with clinical vendors to resolve contracting challenges
• Drive the Fair Market Value (FMV) process with study teams and vendors to finalize work orders and change orders
• Establish and manage the vendor governance process with key clinical vendors; document decisions and ensure governance compliance
• Collaborate with study teams to establish KPI processes and standard clinical vendor KPIs
• Collaborate with legal and clinical operations to establish template clinical site contracts/CTAs
• Build template site budgets utilizing an FMV tool; may help negotiate budgets with clinical sites
• Attend Study Execution Team (SET), monthly budget, and clinical meetings; 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 in clinical research, biotech, and/or pharmaceutical companies
• 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 of scientific collaborators
• Experience providing thought leadership and consistent customer service
• Expertise in clinical contracting processes including CDAs, SOW, FMV assessment, contract negotiations and management, Work Orders, COs, and Budget
• Demonstrated leadership in fast-paced, changing environments

Knowledge / Skills

• BS or MS in a relevant discipline
• Deep knowledge of the clinical research process and regulatory environment
• Legal, financial, clinical operations, and regulatory acumen
• Strong writing, analysis, benchmarking, contracting, and negotiating skills
• Strategic thinker to establish outsourcing norms across the Clinical Department
• Knowledge of ongoing and new development clinical programs
• Understanding of costs of clinical procedures and data processing for estimating programs
• Proficient in systems to manage contracting, finance, and invoicing

Education

• BS or MS in a relevant discipline

Additional Requirements

• Travel up to approximately 10‚Äì15%