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Climb Bio · 7 hours ago

Clinical Program Lead - Associate Director/Director

Wellesley, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

8+ years exp

Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. They are seeking a highly motivated Associate Director, Clinical Operations – Program Lead to oversee the integrated clinical operations plan for a therapeutic asset and ensure alignment across all studies.

BiotechnologyHealth CareNeurosciencePharmaceutical

Responsibilities

Own the integrated clinical operations plan for a therapeutic asset across all studies

Translate clinical development strategy into executable operational plans, timelines, and resourcing

Manage program-level risks, dependencies, and critical path; escalate issues proactively

Maintain visibility into CRO, vendors, and investigational site metrics

Review and approve study-level plans, deliverables, and metrics to ensure consistency across the program

Hold CROs and vendors accountable for quality, performance, and budget

Partner with Legal and Finance to align on contract language, ensure compliance with company policies, and streamline contract workflows

Own development and ongoing management of program level clinical budgets across all studies, ensuring alignment with operational plans and study timelines

Partner with Clinical Development, Regulatory, CMC, Data Management, Biostats, Safety, and Quality to deliver program milestones and ensure continuity and consistency across the programs

Represent Clinical Operations in asset-level planning and governance discussions

Support operational readiness for regulatory milestones and inspections

Matrix management of clinical operations team members, may manage and develop direct reports

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, including timelines, risks, and trade-offs

Ensure inspection-ready TMF and compliance with ICH-GCP, SOPs, and regulatory requirements

Support audits, inspections, and continuous improvement initiatives

Contribute to Clinical Operations SOPs, tools, and best practices

Partner with the VP to scale the Clinical Operations function as the pipeline grows

Qualification

Clinical operations experienceTrial managementCRO oversightGCP guidelines knowledgeRegulatory requirements knowledgeMS Suite proficiencyAnalytical skillsCommunication skillsProblem-solving skillsAttention to detail