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Role Summary The Head of Development Services is responsible for building and overseeing the operational backbone that enables efficient, compliant, and scalable clinical development. The role leads centralized development services—including Business Operations, Trial Master File (TMF) Management, and Vendor Relationship & Management—ensuring consistency, transparency, and quality across the development portfolio. The role is a member of the Development Operations & Biometrics leadership team, and as such, participates in senior leadership meetings and strategic initiatives across the development organization.

Key Responsibilities

• Establish and lead centralized development services supporting all clinical programs
• Build and lead development services organization, including Business Operations, TMF Management, and Vendor Relationship & Management functions and identifying functions scaled to meet the growing needs of the development portfolio
• Own the TMF strategy & operating model, ensuring TMF completeness, inspection readiness, and regulatory compliance across development functions
• Oversee the Business Operations function including Clinical Sourcing & Procurement and Contract & Budgets functions
• Partner with Finance & Operations to forecast clinical development costs and optimize spend
• Oversee end-to-end management of vendor and site contracts and oversight of forecasts, accruals, and variance management
• Establish comprehensive & scalable preferred vendor governance frameworks, including selection, contracting, performance management, and oversight aligned with portfolio needs
• Drive competitive RFP processes, vendor selection, rate cards, and negotiation strategies
• Partner with Quality to address vendor audits, CAPAs and compliance issues
• Drive standardization of processes, metrics, and reporting across development
• Provide portfolio-level operational insights to support executive and Board decision-making
• Ability to assess and transform capabilities through AI and Automation solutions or strategies
• Develop and lead a high-performing development services organization
• Up to 20-30% domestic and international travel, as required.

Qualifications & Preferred Skills

• Bachelor's degree in life sciences, business, or related field
• 15+ years of experience in development operations leadership, development services, or related roles.

Or advanced degree (PhD, MBA, Masters) and 12+ yrs of experience

• Proven experience building centralized operational functions in biotech or pharma
• Strong vendor governance, TMF, and operational excellence background
• Strong Understanding of global clinical trial operations and regulatory requirements
• Experience supporting multiple phases of development, including late stage registrational trials
• Strategic sourcing & negotiation expertise
• Strong Financial Acumen & budget management
• Deep understanding of vendor governance, performance, and inspection management
• Executive-level communication and stakeholder management
• Ability to scale to meet the needs of the business and portfolio