Director, Toxicology

Responsibilities

• Designs and oversees non-GLP and GLP nonclinical safety programs to advance Pliant’s pipeline of small and large molecule therapeutics for global submissions
• Develops and implements target de-risking and screening strategies in discovery teams to support safety lead optimization efforts
• Serves as the nonclinical safety subject matter expert, contributing to cross-functional program strategy and decision-making
• Collaborates closely with internal cross-functional groups such as Pharmacology, ADME-PK, BA, CMC, Regulatory Affairs, Clinical Development, and Project Management
• Analyzes, interprets, summarizes, and presents nonclinical safety data to internal teams and senior leadership
• Authors and reviews safety pharmacology and toxicology sections of global regulatory documents for IND and post-IND stage programs and acts as a nonclinical point of contact for any information requests
• Represents the organization in interactions with global health authorities, including preparation for and participation in agency meetings
• Authors SOPs in collaboration with QA and in compliance with US and OECD GLP guidelines
• Provides scientific oversight of external CROs and vendors, ensuring high quality, timely, and cost-effective safety assessment
• Authors publications and presents externally at scientific meetings, as corporate needs arise

Qualifications

• PhD in Toxicology, Biology, Pharmacology or related scientific discipline; Board certification (DABT) required
• 10+ years of relevant industry experience in nonclinical safety evaluation across drug discovery and development
• Demonstrated expertise in small and large molecule Discovery/Regulatory Safety Assessment and regulatory toxicology guidelines, requirements, and standards (GLP, OECD, ICH, CTD, etc.)
• Proven ability to develop and implement nonclinical strategies that support clinical progression and regulatory approval
• Strong scientific judgement, critical thinking, and problem-solving capabilities
• Excellent written and verbal communication skills, including regulatory document authorship and executive-level presentation experience
• Demonstrated ability to work effectively and collaboratively on cross-functional project teams
• Ability to thrive in a fast-paced biotech environment, balancing strategic leadership with operational execution and timely decision-making

Pay

The annual base salary for this role is $232,000 – $256,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training.

Benefits

Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.

Contact Information

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