Associate Director, Clinical Outsourcing

The Associate Director, Clinical Outsourcing will lead the strategic identification and selection process with Clinical teams for clinical vendors and Clinical Research Organizations (CROs), lead negotiations, and scope specifications for clinical programs.

In close collaboration with Legal and Finance, the position will be responsible for driving the development of key document templates and negotiation parameters, processes, and additional infrastructure to support drug development contracts.

Reporting to the Senior Director, Clinical Outsourcing, the Associate Director, Clinical Outsourcing will coordinate selection of all Clinical Development vendors and be able to identify and leverage efficiencies across programs.

The position will partner closely with Clinical Development, Clinical Quality, Finance, Legal, Global Project Management and additional functional leaders to understand the project or study priorities to support timely delivery of negotiated contracts and budgets.

Duties and responsibilities

20% Strategic Planning Coordinates outsourcing activities across assigned clinical development programs. Meets with project teams to gain an understanding of the scope of work and priorities of the various projects.

Works with study teams to determine overall outsourcing strategy. Guides project teams through the outsourcing process and gives appropriate suggestions and advice on the best approach / best practices.

Implements defined outsourcing process to develop necessary documents; e.g., SOW template, transfer of obligations chart, payment schedule, kickoff meeting agendas, etc.

Formulates and harmonizes project scopes, plans, strategies, and budgets for assigned studies / programs. Aids in the evaluation of potential outsourcing vendors (through effective bidding process and capabilities presentations).

50% Vendor management : 15 25 Vendor per study Participates in scheduling, organizing, and facilitating kickoff meetings with vendors.

Participates team meetings with vendors. Supports the project teams to assure the quality and timeliness of deliverables through outsourcing.

Monitors and manages relationships with contracted vendors; facilitates the resolution of issues and conflicts. Supports organizational governance activities with vendors.

Works with Project Teams to ensure outsourced clinical trial activities meet quality standards and expectations and adheres to applicable Corporate SOPs, WPs, policies, guidelines, and regulations.

Ensures smooth and effective communication between the vendors and the company. Ensures Vendors / CROs are accountable and Identifies issues and develop solutions Facilitates the closure of each study / contract with the vendor, including a mutual assessment of performance..

30% Vendor selection and contract negotiation : Guides and participates in the evaluation, selection, and negotiation of contracts for assigned studies / programs.

Works with Project Managers and Project Teams to develop RFPs. Works with Project Managers and Project Teams for all operational, scheduling, project budget and cost-saving considerations for assigned studies / programs.

Liaises with project teams to develop the Statement of Work (SOW) for each contract; coordinates the SOW review and finalization process.

Negotiates new and amended work specifications, budgets, payment schedules, relationship management plans, and other documents that control the activities and performance of contract service providers..