Director, Clinical Outsourcing and Finance

The Director of Clinical Outsourcing and Finance will be responsible for leading the clinical outsourcing function, including the selection, contracting, oversight, and performance management of external partners. The role also includes responsibility for clinical financial planning and analysis, including developing financial plans, forecasting, budgeting, and evaluating the key drivers that impact financial performance. As a key member of the cross-functional development team, this individual will build scalable outsourcing and procurement processes appropriate for a growing biotechnology company.

The role requires a strategic, commercially minded leader who is equally comfortable developing long-term sourcing strategies and personally leading vendor selection, contract negotiations and supplier governance. The primary objective of the role will be to drive value through outsourcing including vendor strategy, governance and financial planning and analysis.

Working closely with the Chief Operating Officer, Clinical Operations, Medical, Biometrics, Regulatory, Quality, Legal and the VP, Finance, the Director will establish high-performing external partnerships that enable efficient, cost-effective and high-quality clinical trial execution.

• Develop and implement the Company's outsourcing strategy to support clinical development from early through late-stage studies.
• Advise senior leadership on outsourcing models, vendor capabilities, market trends and commercial opportunities.
• Build an outsourcing framework that is scalable as the organization grows.
• Balance quality, timelines, cost and operational risk when making sourcing recommendations.

• Lead sourcing activities for CROs, central and specialist laboratories, imaging providers, eCOA/eClinical vendors, specialist service providers and other clinical suppliers.
• Support Chemistry, Manufacturing, and Controls (CMC) with vendor selection and contract management as necessary
• Develop and manage RFIs, RFPs and vendor selection processes.
• Perform commercial and operational assessments of prospective vendors.
• Recommend supplier selection based on capability, quality, experience, delivery and value.
• Negotiate competitive commercial arrangements while protecting the Company's interests.
• Ensure contracts appropriately allocate operational and financial risk.
• Partner with Procurement and Finance team to finalize Master Service Agreements, Statements of Work, Change Orders and related contracts.
• Work with Functional Leads to establish and maintain strong relationships with strategic suppliers.
• Develop supplier governance processes including KPIs, business reviews and performance monitoring.
• Drive proactive issue resolution and continuous improvement initiatives.
• Work collaboratively with functional teams to ensure vendors consistently deliver to expectations.

• Develop annual financial plan and long-range clinical plans
• Perform financial return analysis for new development programs to assist in capital allocation
• Review and sign off on all clinical vendor bills ensuring financial accuracy and compliance with contractual terms
• Identify opportunities for efficiency and cost optimization without compromising quality or timelines.

• Contribute to the continuous improvement of fit-for-purpose procurement policies, templates and standard operating procedures.
• Introduce practical systems and tools that support vendor oversight and reporting.
• Ensure processes remain proportionate for a growing biotechnology organization.

• Ensure outsourced activities comply with GCP, GxP and applicable regulatory requirements.
• Partner with Quality Assurance on vendor qualification and oversight activities.
• Identify and mitigate supplier risks, including quality, financial, operational and business continuity risks.
• Maintain inspection and audit readiness relating to outsourced activities.

• With a dotted-line reporting relationship to the VP of Finance build trusted relationships across Finance, Legal, Clinical Operations, Medical, Regulatory,…