Sr. Medical Director
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.
Key Responsibilities:
- 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.
Qualifications:
- 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 10+ years of biotechnology or pharmaceutical industry clinical development experience, with progressive scope and accountability at the program level.
- Demonstrated experience as a clinical lead or medical lead on both Phase 2 and Phase 3 studies, including protocol design, medical monitoring, and clinical data interpretation.
- Experience supporting a program through late-stage development to registration (BLA/NDA/MAA submission and approval) strongly preferred.
- Therapeutic area experience in autoimmune or immune-mediated disease - ideally B-cell targeted therapies, systemic lupus erythematosus, immune thrombocytopenia, membranous nephropathy, or related nephrology/hematology indications.
- Working knowledge of FDA and international regulatory requirements, ICH-GCP, and the clinical evidence expectations for registrational programs; direct experience in health authority interactions.
- Proven ability to set clinical strategy in areas of scientific ambiguity and to translate complex clinical data into clear recommendations for senior leadership, investigators, and regulators.
- Experience operating in a lean, fast-moving clinical-stage organization, with the comfort and judgment to own a broad scope and lead through influence across functions and external partners.
This position is a hybrid role and will be based out of our Wellesley, MA office.
Base salary offered may vary depending on the individual's skills, experience, and competitive market value.
Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, Life & Disability, 401k company match, generous paid time off, and equity.
