Climb Bio

Director

• 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.

Director, Non-Clinical Development

Clinical Research

• Serve as the Clinical Operations representative on project teams, leading study-level operational execution in partnership with Clinical Development, Regulatory, Data Management, Safety, Statistics, and CMC, and proactively driving alignment and issue resolution
• Accountable for end-to-end trial ownership, including clinical trial conduct, study-level inspection readiness, TMF health, documentation discipline, investigational product supply and regulatory submissions support, with responsibility for proactive study-level risk assessment, prioritization, and escalation
• Operate effectively in a fast‑moving biotech environment, demonstrating resilience, sound judgement under pressure, and the ability to adapt execution approaches while maintaining quality and compliance amid shifting priorities
• Partner with senior Clinical Operations leadership on study and asset clinical strategy, issue solving, and development of high-quality, inspection‑ready operational approaches
• Support study startup and ongoing management in alignment with GCP, SOPs, and quality standards
• Serve as the study‑level operational lead during audits and regulatory inspections, including preparation, inspection support, and execution of responses and CAPAs
• Lead CRO and vendor execution with clear accountability for quality, timeline, and budget performance, exercising judgement to resolve issues, recommend trade-offs, and escalate risks as appropriate
• Support senior team members in tracking clinical expenses and budgets
• Prepare timely, accurate trial status reports for leadership

Director, Non-Clinical Development

Senior Clinical Trial Manager