Director, Toxicology

The Director of Toxicology will lead a critical scientific area responsible for toxicology and safety pharmacology activities supporting Enanta’s discovery and development portfolio. This individual will develop and execute nonclinical safety strategies, lead internal and external teams, and ensure delivery of high-quality scientific and regulatory outputs across multiple programs.

The Director will influence scientific strategy and investment decisions, translate portfolio priorities into operational plans, and drive achievement of critical milestones. Working cross-functionally with research, clinical development, regulatory affairs, CMC, and external partners, this individual will provide strategic guidance, identify and mitigate safety risks, and ensure alignment on priorities, resources, timelines, and key decisions.

The position may be filled at the Director or Senior Director level based on the selected candidate’s experience, leadership scope, and demonstrated ability to influence scientific and organizational strategy.

• Lead toxicology and safety pharmacology activities across multiple discovery and development programs, including oversight of internal teams, consultants, and external partners.
• Develop and execute integrated nonclinical safety strategies aligned with program, regulatory, and organizational priorities.
• Direct the design, execution, interpretation, and reporting of GLP and non-GLP toxicology studies, including in vitro, general, reproductive, developmental, genetic, and specialized toxicology assessments, and safety pharmacology.
• Drive cross-functional alignment on study plans, scientific findings, risks, decisions, and program priorities.
• Manage resources, budgets, CROs, and functional processes to ensure quality, compliance, efficiency, and timely delivery.
• Set clear goals, drive accountability, and develop scientific talent to build a collaborative, high-performing team.

• Ph.D., DVM, or equivalent advanced degree in toxicology, pharmacology, or a related scientific discipline, with significant experience leading nonclinical safety activities in a biotechnology, pharmaceutical, or comparable industry setting.
• Experience as the toxicology lead on successful IND, CTA or NDA submissions, including direct regulatory agency interactions.
• 10+ years of relevant toxicology or safety assessment experience with demonstrated progression into scientific and people leadership roles, including hands‑on experience designing study protocols and managing CROs.
• Advanced scientific expertise in general toxicology, safety pharmacology, developmental and reproductive toxicity, carcinogenicity, in vitro toxicology, study design, data integration and interpretation, risk assessment, and global regulatory requirements, including FDA, EMA, and ICH.
• Proven ability to lead complex research or development programs across internal and external teams, translate scientific strategy into executable plans, and deliver critical milestones through influence, collaboration, and sound scientific judgment.
• Experience managing scientific teams, external partners, operational plans, resources, and budgets, with a track record of establishing clear expectations, coaching talent, addressing performance, and building organizational capability.
• Strong communication and cross‑functional influencing skills, including the ability to clarify needs, influence decisions using data and logic, navigate ambiguity, resolve conflicts constructively, and communicate complex scientific data to senior leadership and regulatory authorities.

• Board certification in toxicology, such as DABT, or an equivalent professional credential.
• Experience…