Director, Non-Clinical Development

Climb Bio

Director/Sr. Director in biotechnology, overseeing non-clinical R&D strategy and execution for drug development.

Posted 4/26/2026full-timeWellesley Hills • Massachusetts • 🇺🇸 United StatesSenior💰 $200,000 - $271,728 per yearWebsite

About the role

Key responsibilities & impact

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.
Contribute to regulatory strategy and documentation for IND submissions and other regulatory filings.
Present data, translational rationale and go/no go recommendations to senior leadership.

Requirements

What you’ll need

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.

Benefits

Comp & perks

discretionary annual bonus
comprehensive benefits to include Medical, Dental and Vision
Life & Disability
401k company match
generous paid time off
equity

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

translational sciencebiomarker identificationassay developmentpreclinical drug developmentIND-enabling studiesPK/PDsafety pharmacologytoxicologyclinical trial designdata quality

Soft Skills

strong judgmentexcellent written communicationexcellent oral communicationrisk anticipationdecision-makingcollaborationaccountabilityleadershipstrategic thinkingproblem-solving

Certifications

PhD in biologyPhD in pharmacologyPhD in toxicology