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United States
Remote only
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Development Outsourcing based in the United States.
The Associate Director, Development Outsourcing will lead vendor sourcing, contracting, and relationship management activities supporting clinical development programs from Phase I through Phase IV. This role offers the opportunity to shape effective outsourcing strategies and ensure external partners deliver against program objectives, timelines, and quality expectations. Working closely with Development Operations, Clinical Quality Assurance, Legal, Finance, and cross-functional study teams, you will drive vendor selection, contract execution, performance oversight, and issue resolution. You will independently manage complex outsourcing activities while providing practical guidance and recommendations to stakeholders. As part of a fast-paced biotechnology environment, you will help strengthen vendor governance, mitigate operational risks, and continuously improve processes and tools. This is a fully remote position with periodic travel required for team and organizational events.
Serve as the primary Development Outsourcing lead for assigned studies and programs, partnering with cross-functional teams and external vendors to support successful execution.
Implement outsourcing strategies established by Development Outsourcing leadership while independently managing day-to-day vendor activities across multiple studies.
Advise study teams on vendor selection, contracting approaches, oversight strategies, and operational issue resolution.
Ensure outsourcing deliverables, timelines, and decisions remain aligned with study objectives and are executed efficiently.
Lead vendor sourcing and evaluation activities, including preparing requests for information (RFIs) and proposals (RFPs), reviewing proposals, coordinating bid defenses, conducting comparative analyses, and developing vendor recommendations.
Lead the development, negotiation, and execution of vendor agreements, including Confidentiality Agreements, Master Service Agreements, Statements of Work, Change Orders, rate cards, Letters of Intent, and related contracts.
Collaborate with Legal, Finance, and study teams to facilitate contract execution and resolve business or operational issues affecting study startup and delivery.
Act as the primary day-to-day outsourcing contact for assigned vendors and studies, proactively identifying and addressing operational challenges, risks, and decisions.
Escalate significant risks, relationship concerns, performance issues, and strategic decisions to leadership while ensuring agreed actions are completed.
Support vendor governance by preparing meeting materials, tracking action items, monitoring performance metrics, and following through on commitments.
Monitor vendor performance and coordinate corrective and preventive actions when required.
Partner with Development Operations, Clinical Quality Assurance, Legal, Finance, and other stakeholders to maintain effective vendor oversight and execution.
Support vendor qualification, audit readiness, inspection preparedness, and oversight activities in collaboration with Clinical Quality Assurance.
Maintain accurate documentation covering vendor selection, contracting, governance, performance management, and issue resolution.
Contribute to continuous improvement initiatives involving outsourcing processes, tools, templates, and best practices.
Balance urgent operational needs, strategic priorities, and routine responsibilities across multiple concurrent activities in a dynamic environment.
Exercise sound judgment and independent decision-making, identify and resolve obstacles, and recognize when leadership input or escalation is needed.
8–12 years of experience in biotechnology, pharmaceuticals, contract research organizations (CROs), or related research environments, with substantial experience in Development Outsourcing, Clinical Operations, Vendor Management, or a related function.
Strong understanding of clinical development and outsourced service delivery models across Phases I–IV.
Demonstrated experience leading vendor sourcing initiatives, RFP processes, bid defenses, contract negotiations, and vendor oversight activities.
Hands-on experience negotiating and managing Master Service Agreements, Statements of Work, Change Orders, and other vendor-related contracts.
Proven ability to independently manage complex outsourcing activities across multiple studies, vendors, and stakeholders.
Strong business judgment, organizational skills, and the ability to prioritize competing demands in a fast-paced, evolving environment.
Ability to identify risks, make timely decisions, resolve operational challenges, and work effectively with limited direction.
Excellent communication, negotiation, influencing, and relationship management skills.
Demonstrated ability to collaborate across cross-functional and matrixed organizations, aligning diverse stakeholders around shared objectives.
A proactive, accountable approach to problem-solving, decision-making, and delivering on commitments.
Salary: Anticipated annual salary range of $175,000–$190,000, depending on relevant experience, educational background, geographic location, and other job-related factors.
Remote work: Fully remote position within the United States.
Travel: Periodic travel for team meetings and organizational events.
Equal opportunity: Commitment to fair and equal employment consideration in accordance with applicable laws.