Clinical Program Lead - Wellesley - Climb Bio

    Climb Bio
    Climb Bio Wellesley

    1 week ago

    Description

    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 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, Clinical Operations – Program Lead. Reporting to the VP, Clinical Operations, this individual will be the primary execution lead for budoprutug.

    Key Responsibilities


    Program‑Level Operational Execution

    • 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; escape 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.

    Cross‑Functional Leadership

    • 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.

    People Management

    • 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.

    Governance, Reporting & Quality

    • 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.

    Process & Scale

    • Contribute to Clinical Operations SOPs, tools, and best practices.
    • Partner with the VP to scale the Clinical Operations function as the pipeline grows.

    Qualifications

    • 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%).

    Key Competencies

    • 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.

    This role has the option of being remote or based out of our office in Wellesley, MA.

    Base salary offered may vary depending on individual's skills, experience, and competitive market value. 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.

    Climb is a publicly traded company. For more information, please visit

    Climb is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.


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