About the role
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 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.
Position Location
This is a remote role; periodic travel to team and company events is required.
The anticipated salary range for candidates for this role is$175,000 - $190,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.
As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster.
Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Originally posted on Himalayas