Associate Director/Director, Clinical Program Lead

Climb Bio•Newton, MA

29d•$174,000 - $260,000•Hybrid

About The Position

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 CLYM116, 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 CLYM116 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 CLYM116 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.

Requirements

Bachelor’s degree, preferably in life sciences or a related field.
Associate Director Level candidates will have at least 10 years of clinical operations experience and Director level candidates will have at least 12 years of clinical operations experience; including hands on trial management.
At least 3 years of experience in a small biotech
Demonstrated experience overseeing CROs and vendors, and building external development partnerships, ensuring alignment with global standards and regulatory expectations
In-depth knowledge of clinical research processes, GCP guidelines, and regulatory requirements
Excellent communication and interpersonal skills with a focus on managing external relationships effectively
Proficiency in MS Office Suite
Ability to travel occasionally (approximately 15%)
Strategic planning: Ability to lead a critical program or domain with autonomy; at the Director level directs the operational strategy of the program and is accountable for its performance.
Problem Solving & Judgment: Works on complex, ambiguous problems with limited precedent; exercises independent judgment across methods and evaluation criteria; translates development strategy into functional plans.
Collaboration & Influence: Builds strategic partnerships across the organization and with external parties; identifies and mitigates cross-functional friction early; reconciles competing viewpoints and is seen as a connector and go-to thought partner.
Highly organized with attention to detail and commitment to quality
Ability to work effectively with external partners in a dynamic, fast-paced environment

Responsibilities

Serve as the operational lead for the CLYM116 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 as needed to ensure delivery.
Provide ongoing coaching, feedback, and performance management as needed.
Lead operational status reporting for assigned asset, including timelines, risks, and trade-offs.
Ensure inspection-ready TMF and compliance with ICH-GCP, SOPs, and regulatory requirements across asset studies.
Support audits, inspections, and continuous improvement initiatives.
Contribute to or lead the design and implementation of scalable clinical operations frameworks, including governance models and sponsor oversight systems.
Drive standardization across asset studies to enable efficient scaling of the clinical portfolio.
Partner with Clinical Operations leadership to scale the Clinical Operations function as the pipeline grows.