Sr. Medical Director

Climb Bio, Inc.; Wellesley (MA); Hybrid; USD 305,000 - 410,000; Full time

Benefits offered by this job

Discretionary annual bonus

Medical, Dental & Vision

Life & Disability

401k company match

Generous paid time off

Equity

Job summary

Climb Bio, Inc. in Wellesley, MA invites applications for a Sr. Medical Director, Clinical Development. You will lead medical and scientific direction for budoprutug, shaping strategy for Phase 2/3 and pivotal studies toward registration.

Ideal candidates have 5+ years in biotech/pharma clinical development, with evidence of leading Phase 2/3 programs, regulatory interactions, and autoimmune disease experience. Hybrid role based in Wellesley, MA with comprehensive benefits and equity.

Qualifications

• MD or MD/PhD required with clinical training in a relevant specialty.
• Minimum of 5+ years of biotech/pharma clinical development experience at the program level.
• Proven experience as clinical lead on Phase 2 and Phase 3 studies, including protocol design and monitoring.
• Experience supporting a program through late-stage development to registration (BLA/NDA/MAA).
• Therapeutic area experience in autoimmune or immune-mediated disease.
• Knowledge of FDA/ICH-GCP and regulatory expectations for registrational programs.

Responsibilities

• Serve as clinical lead for budoprutug across registration
• Drive clinical development strategy, study design, endpoints, and evidence for registration
• Author and own core study documents and safety/efficacy data interpretations
• Medical monitor for studies: safety reviews, dose guidance, protocol conduct
• Collaborate with safety, pharmacovigilance, and cross-functional teams to deliver studies on time
• Prepare for health authority interactions and contribute to briefing documents and submissions
• Provide medical oversight of CROs, labs, and external committees
• Engage with investigators, KOLs, and external engagements; support publications and congresses
• Represent Clinical Development in governance forums and portfolio decisions

Skills

Clinical leadership

Study design

Regulatory strategy

Cross-functional collaboration

Medical monitoring/safety

Education

M.D. or M.D./Ph.D.

Job description

About Climb

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 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

• 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 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.

• Salary: $305,000-$410,000

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.

For more information, please visit climbbio.com.

Climb is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.