Director/Sr. Director, Non-Clinical Development

Climb Bio•Wellesley, MA

7d•$200,000 - $316,000•Hybrid

About The Position

Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases, including budoprutug and CLYM116. The company's core values are Build Trust, Decide & Commit, Accelerate Impact, and Mark the Moment. The Director/Sr. Director, Non-clinical Development will lead the 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.

Requirements

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.

Responsibilities

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.
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.
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.
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.
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.