Associate Director – Development Outsourcing

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $175k - $190k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 1%

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Jade Biosciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

📋 Description

• Serve as the primary Development Outsourcing lead for assigned studies and programs • Partner with cross-functional study teams and external vendors to ensure successful execution of outsourcing activities • Implement outsourcing strategies and independently manage day-to-day vendor-related activities • Advise study teams on vendor selection, contract strategy, oversight, and issue resolution • Ensure outsourcing deliverables, timelines, and decisions align with study objectives • Lead vendor sourcing and evaluation, including RFI/RFP preparation, proposal review, bid defense coordination, comparative analyses, and recommendations • Lead development, negotiation, and execution of vendor agreements, including Confidentiality Agreements, Master Service Agreements, Statements of Work, Change Orders, rate cards, and Letters of Intent • Partner with Legal, Finance, Development Operations, Clinical Quality Assurance, and other stakeholders on contracts and vendor oversight • Act as the day-to-day outsourcing representative for assigned vendors and studies • Identify and resolve 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 executed • Monitor vendor performance and support corrective and preventive actions • Support vendor qualification, audit readiness, inspection preparedness, and oversight activities • Maintain vendor selection, contracting, governance, performance management, and issue-resolution documentation • Contribute to continuous improvement of Development Outsourcing processes, tools, templates, and best practices • Balance urgent issues, strategic priorities, and routine responsibilities across multiple concurrent activities • Exercise independent judgment, drive decisions, resolve obstacles, and ensure commitments are completed

🎯 Requirements

• 8-12 years of biotechnology, pharmaceutical, CRO, or contract research experience with significant 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 • 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 and stakeholders • Strong business judgment, organizational skills, and ability to prioritize effectively in a dynamic environment • Ability to identify risks, make timely decisions, and drive resolution of issues with limited direction • Strong communication, negotiation, influence, and relationship management skills • Experience collaborating effectively 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