Senior Director Toxicology (Non-Clinical Development)

Genepool Networks; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Genepool Networks is seeking a Director/Senior Director of Non-Clinical Development to lead safety strategy across the pipeline, from IND-enabling studies to NDA submissions, and to drive regulatory positioning of safety programs.

The role requires deep toxicology expertise, leadership across programs, and strong collaboration with cross-functional teams to support global filings and benefit-risk assessments in a fast-paced biotech environment.

Qualifications

• PhD, DVM or equivalent advanced degree in Toxicology or related field.
• 10+ years in nonclinical development with leadership in toxicology.
• Deep expertise in toxicology and safety assessment for pharmaceutical development.
• Experience supporting IND submissions and clinical development programs.
• Experience designing and managing outsourced toxicology studies and CRO partnerships.
• Strong understanding of ICH guidance, GLP regulations, and global nonclinical requirements.
• Proven authorship or major contribution to regulatory documents and health authority interactions.
• Excellent communication and scientific presentation skills.

Responsibilities

• Lead nonclinical safety strategy from IND-enabling studies through NDA submission.
• Represent toxicology on cross-functional teams, supporting development strategy and risk assessment.
• Design, oversee, and interpret toxicology studies across key disciplines.
• Assess safety risks and develop mitigation strategies aligned with regulatory expectations.
• Manage external CROs, including study execution, budgets, timelines, and reporting.
• Support clinical development through dose selection, monitoring, and safety risk management.
• Author and review regulatory submissions and nonclinical documentation.
• Represent toxicology in interactions with global health authorities.
• Communicate safety findings to internal and external stakeholders.
• Drive continuous improvement of nonclinical development processes and standards.

Skills

Toxicology leadership

Strategic scientific leadership

Regulatory strategy

Cross-functional collaboration

Education

PhD, DVM or equivalent in Toxicology

Job description

We are seeking an experienced Director/ Senior Director of Non-Clinical Development to provide scientific leadership and execution of nonclinical safety strategies across our pipeline. This individual will serve as the toxicology subject matter expert, leading the design, interpretation, and regulatory positioning of safety assessment programs supporting therapeutics from IND-enabling studies through late-stage development and registration.

This person will contribute strategic scientific leadership across multiple programs, ensuring that toxicology packages appropriately support clinical development, regulatory submissions, and benefit-risk assessments. Success in this role requires strong scientific judgement, experience navigating complex development challenges, and the ability to work effectively in a fast-paced, collaborative biotechnology environment.

Responsibilities

• Lead nonclinical safety strategy from IND-enabling studies through NDA submission.
• Represent toxicology on cross-functional teams, supporting development strategy and risk assessment.
• Design, oversee, and interpret toxicology studies across key disciplines.
• Assess safety risks and develop mitigation strategies aligned with regulatory expectations.
• Manage external CROs, including study execution, budgets, timelines, and reporting.
• Support clinical development through dose selection, monitoring, and safety risk management.
• Author and review regulatory submissions and nonclinical documentation.
• Represent toxicology in interactions with global health authorities.
• Communicate safety findings to internal and external stakeholders.
• Drive continuous improvement of nonclinical development processes and standards.

Qualifications

Required

• PhD, DVM, or equivalent advanced degree in Toxicology, Pharmacology, Veterinary Sciences, or related discipline.
• 10+ years of industry experience in nonclinical development with significant toxicology leadership responsibility.
• Deep expertise in toxicology and safety assessment for pharmaceutical development.
• Demonstrated experience supporting IND submissions and clinical-stage development programs.
• Extensive experience designing and managing outsourced toxicology studies and CRO partnerships.
• Strong understanding of ICH guidance, GLP regulations, and global nonclinical regulatory requirements.
• Proven authorship or major contribution to regulatory documents and health authority interactions.
• Excellent communication and scientific presentation skills.

Preferred

• Experience supporting Phase 3 programs and NDA submissions.
• Experience with small molecules preferred
• Global regulatory experience, including EMA and PMDA interactions.