Sr. Clinical Trial Manager

Climb Bio•Wellesley, MA

5d•Hybrid

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 systemic lupus erythematosus, immune thrombocytopenia, and membranous nephropathy 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 are seeking an experienced, self-motivated Senior Clinical Trial Manager to lead end-to-end delivery of Phase 1 – 3 studies, with immediate emphasis on owning Phase 1/Phase 2 execution and contributing to the development of scalable clinical operations processes. Reporting to the Director of Clinical Operations, this person will play a critical role in enabling Climb to deliver on its mission.

Requirements

Bachelor’s degree
Proven experience in independently managing clinical trials, with a minimum of 6 years’ experience, spanning Phases 1 – 3 of clinical research
At least 2 years’ experience in a small biotech with demonstrated success independently managing multiple trials & building and scaling processes
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 20%)
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, with ability to connect decisions to data integrity and compliance, and to influence and mentor others in quality behaviors.

Responsibilities

Serve as the Clinical Operations representative on project teams, leading study-level operational execution in partnership with Clinical Development, Regulatory, Data Management, Safety, Statistics, and CMC, and proactively driving alignment and issue resolution
Accountable for end-to-end trial ownership, including clinical trial conduct, study-level inspection readiness, TMF health, documentation discipline, investigational product supply and regulatory submissions support, with responsibility for proactive study-level risk assessment, prioritization, and escalation
Operate effectively in a fast‑moving biotech environment, demonstrating resilience, sound judgement under pressure, and the ability to adapt execution approaches while maintaining quality and compliance amid shifting priorities
Partner with senior Clinical Operations leadership on study and asset clinical strategy, issue solving, and development of high-quality, inspection‑ready operational approaches
Support study startup and ongoing management in alignment with GCP, SOPs, and quality standards
Serve as the study‑level operational lead during audits and regulatory inspections, including preparation, inspection support, and execution of responses and CAPAs
Lead CRO and vendor execution with clear accountability for quality, timeline, and budget performance, exercising judgement to resolve issues, recommend trade-offs, and escalate risks as appropriate
Support senior team members in tracking clinical expenses and budgets
Prepare timely, accurate trial status reports for leadership