Description
The Director of Toxicology is a strategic and hands-on scientific leader responsible for shaping and executing nonclinical safety strategies across the discovery and development portfolio. Reporting to the Vice President of Nonclinical Development, this individual serves as the company’s nonclinical safety expert – driving the design, execution, and interpretation of toxicology and safety pharmacology programs from early research through regulatory submission.
This role provides strong scientific and intellectual leadership across cross-functional teams, partners closely with internal stakeholders and external vendors, and represents nonclinical safety in interactions with global regulatory authorities. The ideal candidate is a collaborative, self-directed leader with deep industry experience across all stages of drug development, and a proven track record of U.S. and ex-U.S. regulatory submissions.
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
- Leads investigative efforts into mechanisms of toxicity as needed
- 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
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
- 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
How you work
- Dare to Succeed: Applies scientific curiosity and discipline to challenge assumptions, proactively identify safety risks, and develop innovative toxicology strategies that enable confident decision-making across discovery and development
- Make an Impact: Demonstrates strong ownership of nonclinical safety strategy and execution, driving programs forward with urgency while ensuring high-quality, regulatory-ready results that directly influence pipeline advancement
- One Pliant: Builds strong, trust-based partnerships across functions and with external collaborators, integrating diverse scientific perspectives to align on program strategy and deliver results as a unified team
