Job Description
The Head, Toxicology, will lead and oversee all aspects of toxicology and safety pharmacology for Enanta’s preclinical and clinical drug development focused on developing innovative therapeutics. This role will drive the strategic and scientific direction of toxicology studies, ensuring that all programs are conducted in compliance with regulatory requirements and support the advancement of novel drug candidates. You will work closely with cross-functional teams, including research, clinical development, and regulatory affairs, to facilitate the translation of preclinical findings into safe and effective clinical applications.
What You'll Do - Strategic Leadership & Scientific Oversight:
- Develop and implement a comprehensive toxicology strategy that supports drug discovery and development programs.
- Provide scientific leadership and oversight for all nonclinical safety assessments, including toxicology, safety pharmacology, and risk assessments.
- Ensure alignment of toxicology plans with regulatory strategies to meet the requirements of global health authorities (e.g., FDA, EMA, etc.).
- Lead the design, conduct, and interpretation of preclinical toxicology studies to evaluate the safety of drug candidates.
- Program & Project Management:
- Oversee the planning, execution, and reporting of GLP and non-GLP toxicology studies (acute, sub-chronic, chronic, reproductive, and developmental toxicology).
- Manage relationships with contract research organizations (CROs), ensuring the timely and high-quality delivery of study data and reports.
- Collaborate with internal and external stakeholders to identify and resolve toxicological issues, including formulation, dose selection, and toxicokinetics.
- Regulatory Affairs & Compliance:
- Support regulatory submissions, including preparation of nonclinical sections of Investigational New Drug (IND) applications, New Drug Applications (NDAs), and other regulatory documents.
- Serve as the company's primary subject matter expert in toxicology for interactions with regulatory authorities and advisory boards.
- Ensure compliance with Good Laboratory Practice (GLP) regulations and maintain up-to-date knowledge of evolving regulatory requirements.
- Cross-Functional Collaboration:
- Work closely with research, clinical development, and CMC teams to integrate toxicology data into the overall drug development strategy.
- Provide guidance to clinical teams on potential toxicology issues that may arise during clinical trials.
- Collaborate with business development and executive leadership on due diligence assessments for potential new compounds or in-licensing opportunities.
- Team Leadership & Development:
- Build and lead a high-performing toxicology team, including hiring, mentoring, and professional development of staff.
- Foster a collaborative and innovative work environment, promoting excellence in toxicology and safety sciences.
- Ensure the team stays at the forefront of toxicology science by integrating the latest industry trends and scientific advancements.
What You Bring - Ph.D., DVM, or equivalent advanced degree in toxicology, pharmacology, or related field.
- 12+ years of experience in preclinical safety assessment and toxicology in the biotechnology, pharmaceutical, or CRO industries, with at least 5 years in a senior leadership role.
- Deep knowledge of toxicology, safety pharmacology, and related regulatory requirements (e.g., FDA, EMA, ICH guidelines).
- Proven track record in the successful design, execution, and management of nonclinical safety programs.
- Strong understanding of drug discovery and development processes, including experience in supporting regulatory submissions.
- Excellent leadership and team-building skills, with the ability to manage and mentor scientific teams.
- Exceptional communication and presentation skills, with the ability to influence and collaborate with cross-functional teams and external partners.
What Sets You Apart - Experience with regulatory interactions and successful submission of INDs, NDAs, or BLAs.
- Expertise in the application of new and emerging toxicological methodologies.
Our Core Values At Enanta, we foster a culture driven by the following core values:
- Curiosity : You demonstrate an unrelenting desire to explore, question, and innovate.
- Respectful : You engage with colleagues and partners with professionalism and care.
- Empathy : You are compassionate, both in teamwork and when thinking about patient impact.
- Agility : You thrive in fast-paced environments and adapt quickly to changing circumstances.
- Team-Oriented : You embrace collaboration, understanding that success comes from collective efforts.
- Entrepreneurial Spirit : You are proactive, continuously seeking opportunities to improve and grow.
How to Apply Please complete the application below and include the following attachments:
- Cover Letter
- CV / Resume
- Research Summary (if applicable)
About Enanta Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta’s clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition.
Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit for more information.
E n anta Pharmaceuticals is an equal opportunity employer (EOE) with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, religious creed, gender, gender identity, sexual orientation, physical or mental disability, protected veteran status, or any other class protected by law.
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