Sr. Medical Director – Clinical Development
climbbio · Wellesley Hills
Job description
About the role
Climb Bio is seeking a highly motivated Sr. Medical Director to lead the clinical development of budoprutug, an anti‑CD19 monoclonal antibody targeting B‑cell mediated diseases. Reporting to the VP of Clinical Development, you will drive the program from Phase 2 through registration.
Key responsibilities
- Serve as the clinical lead for budoprutug, shaping strategy, indication sequencing, study design, and the evidentiary package for registration.
- Author and own core study documents, including protocols, informed consent forms, Investigator’s Brochures, statistical analysis plans, clinical study reports, and DSURs.
- Act as medical monitor for assigned studies, overseeing safety, efficacy, dose modifications, and data quality.
- Partner with Pharmacovigilance, Safety, Clinical Operations, Biostatistics, Regulatory Affairs, CMC, Translational Sciences, and Program Management to deliver high‑quality studies on time.
- Prepare for health‑authority interactions, author briefing documents, and contribute to marketing application modules.
- Build relationships with key opinion leaders, investigators, and advisory boards; represent Climb Bio at scientific meetings.
Required profile
- M.D. or M.D./Ph.D. with clinical training in rheumatology, nephrology, hematology, or immunology; board certification preferred.
- 5+ years of biotech/pharma clinical development experience, including leadership on Phase 2 and Phase 3 studies.
- Proven experience guiding programs through late‑stage development to registration (BLA/NDA/MAA).
- Therapeutic expertise in autoimmune or immune‑mediated diseases, especially B‑cell targeted therapies.
- Working knowledge of FDA and international regulatory requirements, ICH‑GCP, and health‑authority interactions.
Required skills
- Clinical trial design and medical monitoring.
- Regulatory strategy and health‑authority communication.
- Cross‑functional leadership and influence across internal and external partners.
What we offer
- Base salary $305,000‑$410,000 per year.
- Discretionary annual bonus, comprehensive medical/dental/vision benefits, life & disability insurance.
- 401(k) company match, generous paid time off, and equity participation.
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Published 6 hours ago
Expires 1 month from now
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climbbio
Wellesley Hills
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