Director, Toxicology

Enanta Pharmaceuticals; Watertown (MA); On-site; USD 173,000 - 250,000; Full time

Job summary

Enanta Pharmaceuticals seeks a Director of Toxicology to lead nonclinical safety strategies across discovery and development. The role includes oversight of internal teams, CROs, and external partners, shaping regulatory outputs and risk management.

You will guide cross-functional programs, influence strategic investments, and build a high-performing team with emphasis on GLP/non-GLP studies and global regulatory interactions (FDA/EMA/ICH).

Qualifications

• Ph.D., DVM, or equivalent advanced degree in toxicology, pharmacology, or related discipline.
• Experience as toxicology lead on IND/CTA/NDA submissions with regulatory interactions.
• 10+ years in toxicology or safety assessment with progression to leadership roles.
• Expertise in general toxicology, safety pharmacology, reproductive and developmental toxicity, carcinogenicity, in vitro toxicology, and regulatory requirements (FDA/EMA/ICH).
• Ability to lead complex programs across internal and external teams, translating strategy into executable plans.
• Experience managing scientific teams, external partners, budgets, and resources.
• Strong communication and cross-functional influencing skills for senior leadership and regulators.

Responsibilities

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

Skills

Toxicology leadership

Regulatory submissions

Cross-functional leadership

Study design

Data interpretation

Risk assessment

CRO management

Budget management

Team leadership

Education

Ph.D., DVM, or equivalent advanced degree in toxicology/pharmacology

Job description

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.

What You’ll Do

• 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.

What You Bring

• 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.

What Sets You Apart

• Board certification in toxicology, such as DABT, or an equivalent professional credential.
• Experience leading toxicology strategy across programs ranging from development candidate selection through late-stage clinical development or registration.
• Expertise in emerging toxicology methodologies, translational safety approaches, alternative nonclinical models, or novel drug modalities.
• Demonstrated success building or scaling a toxicology function, introducing improved processes, and influencing scientific investments across a research organization.

Our 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 bring compassion to teamwork and keep patient impact at the center of decision‑making.
• Agility: You thrive in a fast‑paced environment and adapt effectively as priorities and circumstances evolve.
• Team‑Oriented: You embrace collaboration and understand that meaningful success comes from collective effort.
• Entrepreneurial Spirit: You take initiative and continually seek opportunities to improve, innovate, and grow.

Why Join Us?

At Enanta Pharmaceuticals, you will be part of a team working on projects and programs that truly matter. We offer a supportive, inclusive environment where innovation is not just encouraged but celebrated. You’ll have the opportunity to grow, collaborate, and make a tangible impact.

Enanta is committed to providing compensation transparency. The expected base salary range for this position is $173,000 to $250,000, based on experience, qualifications, and market conditions. Offers will be determined by several factors, including individual experience and expertise, ensuring both equity and competitiveness.

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, STAT6 and MRGPRX2 inhibition.

Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing 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 www.enanta.com for more information.

Enanta 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.