Associate Director, Clinical Outsourcing

Associate Director, Clinical Outsourcing

Full-Time, Permanent,

Cambridge, MA (ideally looking for hybrid ~2 days/week, can be remote)

The Associate Director, Clinical Outsourcing is a key member of the Clinical Operations team, responsible for the strategic selection, contracting, and ongoing oversight of Contract Research Organizations (CROs), central labs, and other clinical vendors across our active development programs. This role partners closely with internal stakeholders to ensure that outsourcing decisions align with program goals, budget parameters, and quality standards. The ideal candidate brings deep CRO/vendor management experience, strong negotiation skills, and a track record of building productive, accountable vendor relationships in a fast-paced biotech setting.

Role Responsibilities:

• Lead Request for Proposal (RFP) processes for CROs, central labs, and specialty vendors across clinical programs

• Evaluate vendor capabilities, capacity, and fit against program requirements; prepare bid defense summaries and selection recommendations

• Negotiate and execute Master Service Agreements (MSAs), Work Orders (WOs), and Change Orders in partnership with Legal and Finance

• Maintain a current vendor landscape across therapeutic areas relevant to our pipeline

• Serve as primary point of contact for CRO and vendor relationships across assigned programs

• Establish governance frameworks including joint operating committees, performance scorecards, and escalation pathways

• Monitor vendor performance against contractual KPIs; lead corrective action discussions when gaps are identified

• Conduct periodic business reviews and contribute to vendor qualification/re-qualification processes

• Partner with clinical study leads and Finance to develop outsourcing budgets and track actuals against forecasts

• Review and approve vendor invoices for accuracy against contracted scope and milestones

• Identify budget risks and opportunities early; communicate proactively to program leadership

• Work closely with Clinical Operations, Regulatory, Finance, and Legal to ensure outsourcing activities are integrated into program planning

• Contribute to the development and continuous improvement of outsourcing SOPs, templates, and best practices

• Support inspection readiness activities related to vendor oversight documentation

• Remote

Required Qualifications:

• BA/BS degree in life sciences, business, or a related field; advanced degree a plus

• Minimum 7 years of clinical operations or outsourcing experience in pharma/biotech, with at least 4 years focused on CRO/vendor management

• Hands-on experience managing full-service and functional service provider (FSP) CRO models

• Strong working knowledge of ICH/GCP guidelines and regulatory requirements governing clinical trial conduct

• Proven ability to negotiate vendor contracts and manage financial accountability across complex outsourcing arrangements