Director/Sr. Director, Non-Clinical Development

Director/Sr. Director, Non-Clinical Development

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.

Role Summary

The Director/Sr. Director, Non-clinical Development leads strategy and execution of all nonclinical R&D activities, serving as the scientific bridge between preclinical research and clinical translation. This role integrates pharmacology, toxicology, and biomarker-driven insights to inform early clinical design, while ensuring programs are scientifically sound, operationally efficient, and positioned for regulatory success.

Key Responsibilities:

Non-Clinical Strategy & Translational Leadership

Define and execute non-clinical development strategies aligned with overall pipeline and corporate goals, with a strong emphasis on translational science that bridges preclinical findings to clinical hypotheses.

Lead pharmacology, toxicology, and translational plans, integrating mechanistic understanding and biomarker data to inform dose selection, go/no-go decisions, and early clinical study design.

Identify and deploy biomarkers to predict efficacy, pharmacological activity, or safety signals in humans, and establish assays to support both preclinical and clinical studies

Ensure scientific rigor, data quality, and clear go/no-go decision-making.

Program Leadership & Execution

Lead IND-enabling studies, including PK/PD, safety pharmacology, and toxicology.

Guide bioanalytical assay development and optimization, as necessary.

Oversee sample management, as required.

Partner closely with CMC, Clinical, Regulatory, and Program Management to ensure seamless transition into the clinic.

Anticipate risks early and course-correct decisively.

Externalization & Vendor Oversight

Select, manage, and hold CROs and academic collaborators accountable for quality, timelines, and budgets.

Serve as the scientific owner and provide active oversight for outsourced studies.

Regulatory & IND Support

Contribute to regulatory strategy and documentation for IND submissions and other regulatory filings.

Integrate non-clinical and translational data packages to support regulatory interactions and, as applicable, early clinical trial applications.

Represent non-clinical strategy in meetings with health authorities as needed.

Executive Communication

Present data, translational rationale and go/no go recommendations to senior leadership.

Translate complex science into clear business-relevant insights that drive decision making.

Keep cross-functional stakeholders informed of non-clinical findings and their implications for program timelines and clinical strategy.

Qualifications

PhD (or equivalent) in biology, pharmacology, toxicology, or related discipline.

8+ years of experience in pre-clinical drug development in biotech or pharma.

Meaningful experience in translational science, including biomarker identification, assay development, and integration of non-clinical data with clinical strategy.

Track record of supporting or contributing to IND-enabling packages and early clinical trial design (Phase 1/2).

Deep experience managing CROs and external collaborators, with high standards for accountability and scientific quality.

Strong judgment—knows when data is “good enough” to move forward.

Excellent written and oral communication skills, with the ability to distill complex data for non-scientific audiences.

This is a hybrid position based out of our Wellesley, MA office. Base salary offered may vary depending on the individual’s skills, experience, and competitive market value.

Salary range for a Director: $200,000-$271,728 

Salary range for Sr. Director: $233,000-$316,000

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.