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Salary: USD 132,000 - 175,000 / annual
Climb Bio is a clinical-stage biotechnology company developing therapeutics for immune-mediated diseases, including candidates like budoprutug (anti-CD19 monoclonal antibody) for systemic lupus erythematosus and immune thrombocytopenia, and CLYM116 (anti-APRIL monoclonal antibody) for IgA nephropathy.
You will serve as the Clinical Operations representative on study teams, leading end-to-end delivery of clinical trials with immediate focus on Phase 1 execution and Phase 2 support. Reporting to the Director of Clinical Operations, you will own study-level operational execution in partnership with Clinical Development, Regulatory, Data Management, Safety, Statistics, and CMC teams.
Key responsibilities include: accountable ownership of clinical trial conduct from startup through completion; ensuring study-level inspection readiness and TMF health; managing investigational product supply and regulatory submissions support; conducting proactive study-level risk assessment and escalation; leading CRO and vendor execution with clear accountability for quality, timeline, and budget; serving as the operational lead during audits and regulatory inspections; and preparing timely trial status reports for leadership.
You will collaborate closely with Senior Clinical Trial Managers on complex studies while demonstrating eagerness to grow into greater study ownership. The role requires operating effectively in a fast-moving biotech environment with resilience, sound judgment under pressure, and adaptability while maintaining quality and compliance.
Required qualifications: Bachelor's degree; minimum 3 years independently managing clinical trials across Phases 1–3, with at least 2 years in biotech managing studies through startup and maintenance; working knowledge of clinical research processes, GCP guidelines, and regulatory requirements; excellent communication and interpersonal skills; proficiency in MS Suite; and ability to travel occasionally (approximately 20%).
Key competencies include strategic planning, analytical and problem-solving abilities, attention to detail, commitment to quality and data integrity, and ability to influence and mentor others in quality behaviors.
