Associate Director, Toxicology

Role Summary

The Associate Director, Toxicology will oversee toxicology and safety pharmacology studies conducted at CROs, ensuring high-quality study monitoring and timely execution to support the development of small molecule orexin receptor agonists. This role works with the Lead Project Toxicologist to manage outsourced toxicology studies, liaise with CRO partners, and ensure regulatory compliance, scientific quality, and on-time delivery of study milestones and reports.

The role will contribute directly to the preparation and delivery of toxicology packages required for IND/CTA submissions and NDA filings.

Location:

Remote, US-based, with significant travel.

• Monitor nonclinical toxicology and safety pharmacology studies conducted at external CROs—via onsite visits or remotely—to ensure scientific quality and full compliance with global regulatory requirements.
• Partner with the Lead Project Toxicologist to share and interpret the findings during study monitoring, and recommend the next steps for improvement.
• Collaborate with the Toxicology Operations Manager and CRO Study Directors to initiate and coordinate internal cross-functional review of draft study protocols and study reports for tox/safety pharmacology studies, engaging DMPK, CMC, and bioanalytical teams as needed.
• Track study progress and deliverables, ensuring timely data transfer, analysis, and interpretation, and provide preliminary assessments to the Lead Project Toxicologist and broader project teams.
• Maintain all study monitoring reports prepared by internal or external study monitors.
• Participate in project sub team meetings to expedite cross-functional execution of study related activities and provide study status updates to project teams upon request.
• Negotiate reporting timelines and expectations with CROs, working directly with Study Directors to agree reporting plans to meet study protocols.

• 8+ years of nonclinical toxicology experience within biotechnology, pharmaceutical, or CRO settings required.
• Prior hands-on oversight of outsourced studies as study monitor or CRO study director in nonclinical toxicological and safety pharmacological studies.
• Demonstrates strong knowledge of GLP compliance and FDA, EMA, and ICH guidance documents and GLP regulations.
• Proven ability to evaluate, interpret, and communicate toxicology data and study outcomes to cross-functional teams and senior project leadership.
• Strong organizational skills with proven ability to manage multiple concurrent studies, track timelines, and maintain high-quality documentation in a fast-paced environment.
• Excellent written and verbal communication skills, including experience preparing or contributing to regulatory documents and study summaries, with strong listening, negotiation, and interpersonal relationship skills.
• Comfortable negotiating timelines, deliverables, and expectations with CRO Study Directors and external partners.
• Self-starter, highly motivated, experienced in toxicology study design and conduct.
• Able to make informed, real-time decisions during onsite CRO visits, ensuring immediate and appropriate resolution of issues that arise during study conduct.

• PhD in Toxicology, Pharmacology, or a related life science discipline; DABT preferred.

• Willing and able to travel at least 50%–60% of the time.