Associate Director/Director, Clinical Program Lead
Listed on 2026-08-09
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Management
Operations Management, Project & Program Management, Regulatory Compliance Specialist, Change Management
Associate Director/Director, Clinical Program Lead
Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates include, budoprutug, an anti-CD19 monoclonal antibody that presents us with an exciting opportunity given its broad potential applicability across a number of B-cell mediated diseases, including primary membranous nephropathy, systemic lupus erythematosus, and immune thrombocytopenia and CLYM
116, an anti-APRIL monoclonal antibody in development for IgA nephropathy.
At Climb Bio, our team has a knack for seeing what no one else sees—and a drive to achieve results no one expects. We believe that our combined strength conquers any summit, and our core values – Build Trust, Decide & Commit, Accelerate Impact, and Mark the Moment – guide how we work, collaborate and innovate. They reflect our commitment to patients, each other, and the pursuit of transformative science.
We are seeking a highly motivated Associate Director/Director, Clinical Program Lead to serve as the operational leader for the CLYM
116 program. Reporting to the VP, Clinical Operations, this role holds accountability for translating clinical development strategy into executable operational plans and for driving compliant, on-time, on-budget execution across all CLYM
116 studies. As the operational engine behind a priority asset advancing toward late-stage development, this leader is critical to Climb Bio's ability to scale its clinical portfolio and deliver for patients.
- Serve as the operational lead for the CLYM
116 program, with accountability for clinical operations execution across studies. - Drive coordinated Clinical Operations planning across studies within the program
- Partner with regional teams, CROs, and country-specific experts across China and broader APAC to ensure aligned, compliant execution of clinical studies
- Drive cross-functional alignment and provide operational input into trade-off decisions
- Translate clinical development strategy into executable operational plans, timelines, and resourcing and provide operational input into cross-functional trade-off decisions.
- Manage program-level risks, dependencies, and critical path across timelines, enrollment, and data delivery milestones; proactively identify risks and implement mitigation strategies, escalating as needed.
- Act as primary oversight of CRO execution—maintaining visibility into CRO, vendor, and investigational site metrics; participating in formal CRO governance (performance reviews, KPIs, escalation frameworks); and intervening decisively to course-correct delivery when performance gaps arise.
- Review and provide operational approval of study-level plans, deliverables, and metrics to ensure consistency across the program.
- Partner with Legal and Finance to align on contract language, ensure compliance with company policies, and streamline contract workflows.
- Own the development and ongoing management of program-level clinical budgets across all studies, ensuring alignment with operational plans and timelines.
- May support additional clinical development programs and/or Clinical Trial Manager as needed, contributing to cross-asset execution and operational continuity.
- Partner with Clinical Development, Regulatory, CMC, Data Management, Biostats, Safety, and Quality to deliver program milestones and ensure continuity and consistency across the programs.
- Lead selected initiatives to enhance operational scalability, consistency, and inspection readiness as programs advance toward late-stage development.
- Represent Clinical Operations in asset-level planning and governance discussions.
- Support operational readiness for regulatory milestones and inspections.
- Support the development and ongoing management of strategic partnerships, helping to build effective, collaborative relationships with key external collaborators.
- Provide matrix management of clinical operations team members, may manage and develop direct reports, holding team accountable for results and values aligned behaviors.
- Set priorities, balance workloads, and step in…
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