Associate Director – Development Outsourcing

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the lead for Development Outsourcing on designated studies and programs.

• Collaborate with cross-functional study teams and external vendors to guarantee the effective execution of outsourcing tasks.

• Develop and implement outsourcing strategies while independently managing daily vendor-related operations.

• Provide guidance to study teams on vendor selection, contract strategy, oversight, and resolution of issues.

• Ensure that outsourcing deliverables, timelines, and decisions are in alignment with study goals.

• Facilitate vendor sourcing and evaluation, which includes preparing RFIs/RFPs, reviewing proposals, coordinating bid defenses, conducting comparative analyses, and making recommendations.

• Oversee the development, negotiation, and execution of vendor agreements, including Confidentiality Agreements, Master Service Agreements, Statements of Work, Change Orders, rate cards, and Letters of Intent.

• Collaborate with Legal, Finance, Development Operations, Clinical Quality Assurance, and other stakeholders on contracts and vendor oversight.

• Serve as the primary outsourcing representative for assigned vendors and studies on a daily basis.

• Identify and address operational issues, risks, and decisions; escalate significant concerns and strategic decisions to leadership.

• Support vendor governance by preparing materials, tracking actions, monitoring performance metrics, and ensuring commitments are fulfilled.

• Oversee vendor performance and assist in implementing corrective and preventive measures.

• Aid in vendor qualification, audit readiness, inspection preparedness, and oversight activities.

• Maintain documentation related to vendor selection, contracting, governance, performance management, and issue resolution.

• Contribute to the continuous enhancement of Development Outsourcing processes, tools, templates, and best practices.

• Manage urgent issues, strategic priorities, and routine responsibilities across multiple concurrent tasks.

• Utilize independent judgment to drive decisions, overcome obstacles, and ensure commitments are fulfilled.

⛳️ Requirements

• 8-12 years of experience in biotechnology, pharmaceuticals, CRO, or contract research, with substantial experience in Development Outsourcing, Clinical Operations, Vendor Management, or a related field.

• Strong comprehension of clinical development and outsourced service delivery models across Phases I-IV.

• Proven experience in leading vendor sourcing initiatives, managing RFP processes, conducting bid defenses, negotiating contracts, and overseeing vendor activities.

• Experience in negotiating and managing Master Service Agreements, Statements of Work, Change Orders, and various vendor-related contracts.

• Demonstrated ability to independently manage complex outsourcing activities across multiple studies and stakeholders.

• Excellent business judgment, organizational capabilities, and effectiveness in prioritizing in a dynamic environment.

• Ability to identify risks, make timely decisions, and resolve issues with minimal guidance.

• Strong skills in communication, negotiation, influence, and relationship management.

• Experience in effective collaboration within cross-functional and matrixed organizations.

• Authorization to work in the United States verified through I-9 and E-Verify.

🏝️ Benefits

• Fully remote work.

• Periodic/occasional travel to team and company events.

• Equal Opportunity employment.