Associate Director, Development Outsourcing

jadebiosciences; United States; À distance; USD 180 000 - 240 000; Plein temps

Résumé du poste

Jade Biosciences is seeking an Associate Director of Development Outsourcing to manage external vendors across Phases I–IV. The role partners with Development Operations and study teams to source, govern, and negotiate vendor engagements. It is a fully remote position with occasional travel.

The successful candidate will lead outsourcing strategies, drive issue resolution, and contribute to process improvements in a fast-paced biopharma environment.

Qualifications

• 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 independent

Responsabilités

• Serve as the primary Development Outsourcing lead for assigned studies and programs, partnering closely with cross-functional study teams and external vendors to ensure successful execution of outsourcing activities.
• Implement outsourcing strategies and plans established by Development Outsourcing leadership while independently managing day-to-day vendor-related activities for assigned studies.
• Provide outsourcing expertise and recommendations to study teams regarding vendor selection, contract strategy, oversight, and issue resolution.
• Ensure outsourcing deliverables, timelines, and decisions are executed efficiently and aligned with study objectives.
• Lead vendor sourcing and evaluation activities in support of Development Programs, including preparation of RFI/RFP materials, proposal review, bid defense coordination, comparative analyses, and recommendation development.
• 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 other vendor-related agreements.
• Partner with Legal, Finance, and study teams to drive contract execution and resolve business or operational issues impacting study startup or execution.
• Act as the day-to-day outsourcing representative for assigned vendors and studies, proactively identifying and resolving operational issues, risks, and decisions.
• Escalate significant risks, relationship concerns, performance issues, or strategic decisions to Development Outsourcing leadership while driving follow-through on agreed actions.
• Support vendor governance activities by preparing materials, tracking actions, monitoring performance metrics, and ensuring commitments are executed.
• Monitor vendor performance and support implementation of corrective and preventive actions when needed.
• Partner closely with Development Operations, Clinical Quality Assurance, Legal, Finance, and other stakeholders to ensure effective vendor oversight and execution.
• Support vendor qualification, audit readiness, inspection preparedness, and oversight activities in collaboration with Clinical Quality Assurance.
• Maintain documentation related to vendor selection, contracting, governance, performance management, and issue resolution.
• Contribute to continuous improvement of Development Outsourcing processes, tools, templates, and best practices.
• Operate effectively in a fast-paced, evolving environment by balancing urgent issues, strategic priorities, and routine responsibilities across multiple concurrent activities.
• Exercise sound judgment and independent decision-making when addressing operational challenges, while recognizing when leadership engagement or escalation is required.
• Demonstrate initiative and accountability by driving decisions, resolving obstacles, and ensuring commitments are completed.

Connaissances

Development Outsourcing

Clinical Operations

Vendor Management

Contract Negotiations

RFP processes

Leadership

Description du poste

About Jade Biosciences

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade's lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated for the treatment of immunoglobulin A nephropathy. Jade's pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an anti-IFN-β monoclonal antibody. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn.

Role Overview

As the Associate Director of Development Outsourcing, you will play a key role in supporting the sourcing and strategic management of Jade's external vendors. This role will partner closely with Development Operations and study teams to support vendor sourcing, contracting, governance, and the development of strong vendor relationships across clinical development programs from Phase I through Phase IV.

The successful candidate will work cross-functionally to drive effective execution, support issue resolution, and contribute to continuous improvement of Development Outsourcing processes. This newly created role will report to the Director, Development outsourcing. This is a fully remote role and will require occasional travel.

Key Responsibilities

• Serve as the primary Development Outsourcing lead for assigned studies and programs, partnering closely with cross-functional study teams and external vendors to ensure successful execution of outsourcing activities.
• Implement outsourcing strategies and plans established by Development Outsourcing leadership while independently managing day-to-day vendor-related activities for assigned studies.
• Provide outsourcing expertise and recommendations to study teams regarding vendor selection, contract strategy, oversight, and issue resolution.
• Ensure outsourcing deliverables, timelines, and decisions are executed efficiently and aligned with study objectives.
• Lead vendor sourcing and evaluation activities in support of Development Programs, including preparation of RFI/RFP materials, proposal review, bid defense coordination, comparative analyses, and recommendation development.
• 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 other vendor-related agreements.
• Partner with Legal, Finance, and study teams to drive contract execution and resolve business or operational issues impacting study startup or execution.
• Act as the day-to-day outsourcing representative for assigned vendors and studies, proactively identifying and resolving operational issues, risks, and decisions.
• Escalate significant risks, relationship concerns, performance issues, or strategic decisions to Development Outsourcing leadership while driving follow-through on agreed actions.
• Support vendor governance activities by preparing materials, tracking actions, monitoring performance metrics, and ensuring commitments are executed.
• Monitor vendor performance and support implementation of corrective and preventive actions when needed.
• Partner closely with Development Operations, Clinical Quality Assurance, Legal, Finance, and other stakeholders to ensure effective vendor oversight and execution.
• Support vendor qualification, audit readiness, inspection preparedness, and oversight activities in collaboration with Clinical Quality Assurance.
• Maintain documentation related to vendor selection, contracting, governance, performance management, and issue resolution.
• Contribute to continuous improvement of Development Outsourcing processes, tools, templates, and best practices.
• Operate effectively in a fast-paced, evolving environment by balancing urgent issues, strategic priorities, and routine responsibilities across multiple concurrent activities.
• Exercise sound judgment and independent decision-making when addressing operational challenges, while recognizing when leadership engagement or escalation is required.
• Demonstrate initiative and accountability by driving decisions, resolving obstacles, and ensuring commitments are completed.

Qualifications

• 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 independent