Associate Director/Director, Data Management

Climb Bio•Newton, MA

2d•Hybrid

About The Position

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 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/Director, Data Management. Reporting to the Vice President, Head of Biometrics, this is a newly created role that will build Climb Bio's Phase 1 through 3 data management capability from the ground up, serving as the operational owner who ensures databases, vendors, and timelines deliver clean, submission-ready data at every milestone.

Requirements

Bachelor's degree in life sciences or a related field
10+ years of clinical data management experience (12+ years for Director-level candidates), including experience taking a database through Phase 3 database lock
Demonstrated experience designing clinical databases and leading user acceptance testing (UAT) execution
Experience managing CRO and data management vendor relationships, including performance oversight
Working knowledge of GCP and applicable regulatory requirements for clinical data management

Nice To Haves

Experience in a small, fast-paced biotech environment
Proficiency with industry-standard clinical database and EDC platforms

Responsibilities

Design and build the clinical database architecture for clinical studies, establishing edit checks, structures, and specifications that meet the program's analysis and regulatory requirements
Own user acceptance testing (UAT) for clinical database builds end-to-end, from test plan development through final sign-off prior to DB going live
Manage data management timelines and deliverables across clinical studies, holding vendors accountable to milestones from first patient in through database lock
Direct the selection and ongoing performance oversight of data management CROs and vendors, serving as the primary escalation point for data quality and timeline issues
Partner with Biostatistics, Clinical Operations, and Regulatory to align data management plans, CRF design, and database specifications with study protocols
Establish data management standards, SOPs, and quality control processes that scale as Climb Bio's clinical portfolio grows
Lead data cleaning, query resolution, and reconciliation activities to ensure inspection-ready, submission-quality data at database lock
Represent Data Management in cross-functional program governance, reporting on database timelines, risks, and trade-offs