Sr. Director, Clinical Pharmacology

Sr. Director, Clinical Pharmacology

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 preclinical 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 an experienced Sr. Director, Clinical Pharmacology. Reporting to the Chief Medical Officer, this individual will be accountable for translating non-clinical and early clinical data into development decisions that enable efficient, scientifically rigorous clinical development.

Key Responsibilities:

Clinical Pharmacology Strategy

• Lead clinical pharmacology strategy across development stages, with initial emphasis on Phase 1 and Phase 2 programs.


• Integrate nonclinical PK/PD, translational data, and early clinical results to inform dose selection, escalation strategies, and regimen optimization.


• Provide clear, data-driven recommendations to support program progression and internal governance decisions.

Study Design & Clinical Execution

• Provide clinical pharmacology leadership in protocol design, including sampling strategies, dose justification, stopping rules, and adaptive features.


• Partner with key R&D stakeholders on population PK, exposure–response, and modeling approaches appropriate to program stage.


• Ensure timely interpretation and communication of PK/PD and biomarker data to clinical teams.

Regulatory & Documentation

• Lead clinical pharmacology contributions to INDs, amendments, Investigator’s Brochures, CSRs, and regulatory documents.


• Participate in regulatory interactions, supporting dose selection rationale and development strategy.


• Ensure consistency and scientific integrity of clinical pharmacology content across submissions.

Vendor & External Partner Management

• Select and manage external vendors and consultants supporting PK bioanalysis, modeling, and related activities.


• Oversee timelines, quality, and deliverables to ensure fit-for-purpose execution in a lean operating environment.

Cross-Functional Leadership

• Serve as the single point of accountability for clinical pharmacology across assigned programs.


• Collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Non-Clinical and CMC.


• Contribute to broader clinical development planning and risk assessment as a core member of the clinical leadership team.

Qualifications:

• PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, or related discipline.


• 8+ years of experience in clinical pharmacology within biotech or pharmaceutical development.


• Hands-on experience in all Phases of clinical development (Phase 1–3).


• Demonstrated ability to influence dose selection and study design.


• Experience contributing to regulatory submissions and interactions.


• Comfortable operating in an environment with ambiguity, speed, and high individual
  


• Experience in Immunology & Inflammation and biologics/antibody drug development preferred.

This is a hybrid position that can be either remote or 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.

Climb is a publicly traded company. 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,