Sr. Medical Director

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 CLYM
116, 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 Sr. Medical Director, Clinical Development. Reporting to the VP, Clinical Development, this role serves as the clinical lead for budoprutug – providing the medical and scientific leadership that carries our lead asset through Phase 2, Phase 3, and pivotal studies to registration, and directly shaping the evidence that brings a new treatment option to patients with B-cell mediated diseases.

• Serve as the clinical lead for budoprutug, providing medical and scientific leadership across through registration.
• Drive the clinical development strategy, including indication sequencing, study design, patient population and endpoint selection, and the evidence package required to support registration.
• Author and own the clinical content of core study and program documents – protocols and amendments, informed consent forms, Investigator's Brochures, statistical analysis plan input, clinical study reports, and DSURs.
• Serve as medical monitor for assigned studies: eligibility and enrollment decisions, ongoing review of safety and efficacy data, dose modification guidance, and medical oversight of protocol conduct and data quality.
• Partner with Pharmacovigilance and Safety on signal detection, aggregate safety review, benefit-risk assessment, and safety governance for the program.
• Lead the clinical workstream of cross-functional study and program teams, partnering closely with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, CMC, Translational Sciences, and Program Management to deliver studies on time and to quality.
• Prepare for and participate in health authority interactions – including End-of-Phase 2 and pre-BLA meetings – and author clinical sections of briefing documents, responses to health authority questions, and marketing application modules (e.g., 2.5, 2.7).
• Provide medical oversight of CROs, central labs, and other clinical vendors, and interface with Data Monitoring Committees, independent adjudication committees, and steering committees.
• Build and sustain relationships with key opinion leaders, investigators, and advisory boards; represent Climb Bio at investigator meetings, scientific congresses, and external engagements.
• Contribute to publications, congress presentations, and scientific communications supporting clinical programs.
• Represent Clinical Development in internal governance forums and provide clinical input to portfolio decisions, lifecycle indication expansion, and diligence activities as needed.

• M.D. or M.D./Ph.D. required, with clinical training in a relevant specialty (e.g., rheumatology, nephrology, hematology, or immunology) strongly preferred; board certification preferred.
• Minimum of 5+ years of biotechnology or pharmaceutical industry clinical development experience, with…