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 outsourcing strategy, and partners with clinical study teams to organize vendor selection, RFP processes, bid defenses, and contract negotiations. 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 RFPs, bid comparison analysis, managing bid defense meetings, and developing vendor scorecards
• Identify service providers for clinical studies in collaboration with study management teams and clinical departments
• Coordinate with legal and financial groups on vendor contracts and purchase orders, negotiating terms as needed
• Develop Scope of Work (SOW) for contracts, including cost negotiations
• Review change notification forms (CNFs) and Change Orders (COs) to ensure correct pricing
• Establish strong partnerships with clinical vendors and develop simplified, collaborative resolutions to contracting challenges
• Drive Fair Market Value (FMV) processes with study teams and vendors to analyze and negotiate work orders and changes
• Establish and manage vendor governance with key clinical vendors, documenting decisions and action plans and ensuring compliance
• Work with study teams to establish KPI processes and standard vendor KPIs for oversight and performance
• Collaborate to establish template clinical site contracts/clinical trial agreements (CTAs)
• Build template site budgets utilizing an FMV tool and negotiate budgets with clinical sites when needed
• Attend Study Execution Team (SET), monthly budget, and clinical meetings; present as needed
• Provide insight and feedback at Clinical Operations Leadership Team
• Lead outsourcing process/tool development, improvement, and implementation

Qualifications

• Knowledge: BS or MS in a relevant discipline is required
• Demonstrates 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 thinker to establish outsourcing norms across the Clinical Department
• Knowledge 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: Minimum of 15+ years in clinical research, biotech, and/or pharmaceutical environment
• Experience managing clinical outsourcing or procurement professionals
• Expertise in building RFPs and leading vendor selection processes
• Strong experience in vendor and site CTA contracting/budgeting, FMV assessment, and engagement of Scientific Collaborators for clinical trials
• Experience providing thought leadership and consistent customer service
• Expertise in the clinical contracting process (CDAs, SOW, FMV, contract negotiations and management, Work Orders, Change Orders, Budget process)
• Demonstrated leadership in a fast-paced, changing environment

• Attributes: Proactive, inclusive engagement; ability to influence cross-functional teams; strong analytical and communication skills; ability to translate strategy into actionable plans; excellent negotiation and interpersonal skills

Education

• BS or MS in a relevant discipline (as noted in Knowledge)

Additional Requirements

• 10-15% travel