Description
About Odyssey Therapeutics
Odyssey is on a mission to transform the standard of care for patients affected by autoimmune and inflammatory conditions. We target
upstream signaling nodes and mechanisms like those in the innate immune system to prevent pathological inflammation before it occurs.
This differentiates our approach from the existing standard of care and unlocks the potential of our therapeutic candidates to induce long-
lasting, deep remission in a safe and effective manner.
At Odyssey, we are creating next generation precision medicines for patients with cancer and inflammatory diseases with class-leading speed, efficiency and rigor through our highly integrated drug hunting engine. In response to recent recruitment fraud, visit our Careers page to verify all job opportunities and read our guidance on this topic: https://odysseytx.com/careers/
Odyssey Therapeutics is seeking an accomplished Senior Director, Toxicology to lead our nonclinical safety strategy and guide the advancement of our expanding pipeline. This role spans discovery through early and late development, supporting multiple therapeutic programs across the organization.
As a senior leader within deeply collaborative biotech environment, you will shape Odyssey’s scientific direction, influence strategic decisions, and help cultivate an innovative, high-performance culture. This is an opportunity to drive programs with significant impact and contribute meaningfully to the evolution of the company.
Your primary objectives will be:
- Lead nonclinical safety strategy across discovery, nonclinical, and clinical development stages for programs in the Odyssey pipeline.
- Oversee all nonclinical safety activities from candidate selection through regulatory submissions and ultimately commercialization.
- Serve as the subject matter expert for GLP and non-GLP toxicology, safety pharmacology, and off-target risk assessment across platform and development programs.
- Author and review nonclinical safety sections of global regulatory submissions (IND/CTA, NDA/BLA/MAA) and lead interactions with regulatory authorities, addressing nonclinical safety questions and issues.
- Deliver high-quality toxicology and safety assessment reports that support clinical program decisions, dose selection, and regulatory filings.
- Proactively develop and execute stage-appropriate nonclinical plans to generate decision-enabling data from late research through regulatory approval.
- Partner cross-functionally with Research, Development, DMPK, CMC, Program Management, and Clinical teams to ensure seamless and efficient program progression.
- Represent Toxicology in internal and external program meetings, providing clear assessments of timelines, data, risk, and program impact.
Conduct periodic CRO oversight, including onsite visits or coordination with Study Monitors, to ensure high standards of study conduct and data integrity.
Requirements
- Doctorate in Toxicology, Pharmacology, Veterinary Sciences, or related field with 12+ years of relevant industry experience. DABT or DACVP certification strongly preferred.
- Extensive experience designing, executing, and outsourcing GLP and non-GLP toxicology and safety pharmacology studies.
- Strong working knowledge of drug discovery and development, including global regulatory expectations and safety-related deliverables.
- Demonstrated experience authoring nonclinical sections of INDs, NDAs/BLAs, and responding to global health authority queries.
- Proven ability to derive safety margins integrating nonclinical toxicity findings with predicted or observed clinical exposures.
- Effective leader and collaborator within cross-functional project teams, able to drive alignment and decision-making.
- Exceptional project management, communication, and scientific writing skills.
- Thrives in a fast-paced, dynamic biotech environment, adept at managing shifting priorities and meeting time-critical deadlines.
- Willingness to travel domestically and internationally to CROs as needed.
