Senior Clinical Trial Manager

Senior Clinical Trial Manager

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.

Key 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

Additional Responsibilities:

• 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

Qualifications:

• 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 of 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%)

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, with ability to connect decisions to data integrity and compliance, and to influence and mentor others in quality behaviors.

This role has the option of being remote or hybrid 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.

Qualified candidates are encouraged to forward their resumes to View email address on click.appcast.io.