Clinical Program Lead - Associate Director/Director

Climb Bio • Wellesley, MA

2d • Remote

About The Position

About Climb:
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.
A 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 are seeking a highly motivated Associate Director, Clinical Operations – Program Lead. Reporting to the VP, Clinical Operations, this individual will be the primary execution lead for budoprutug.

Requirements

• Bachelor’s degree, preferably in life sciences or a related field
• At least 8 years of clinical operations experience, including hands on trial management
• At least 3 years of experience in a small biotech or clinical research organization
• Demonstrated experience overseeing CROs and vendors
• 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 Suite
• Ability to travel occasionally (approximately 15%)
• Strategic planning and organizational skills
• Analytical and problem-solving abilities
• Ability to work effectively with external partners in a dynamic, fast-paced environment
• Attention to detail and commitment to quality

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.

Benefits

• Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, and stock options.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees