Director, Toxicology

Pliant Therapeutics, Inc.•South San Francisco, CA

15h•Onsite

About The Position

Pliant Therapeutics is a clinical-stage biopharmaceutical company and leader in the discovery and development of novel integrin-based therapeutics. Based in South San Francisco, California, Pliant was founded in 2015 to develop therapeutics to modulate specific pathways upregulated or dysfunctional in certain diseases. Our approach involves developing novel integrin-based therapeutics to treat solid tumors and other diseases. Integrins are a crucial link between a cell's internal structure and its external environment and function in cell signaling, regulation and adhesion as well as wound healing and immune response. Founded by a team of world-renowned researchers from the University of California, San Francisco, this group discovered key insights into the integrin biology and developed small molecule therapeutics to target this devastating disease process. Launched in 2016 by Third Rock Ventures, a leading healthcare venture capital firm, Pliant has developed an industry-leading proprietary library of over 15,000 integrins that serve as a key driver to its portfolio. We believe our platform may be broadly applicable across multiple disease areas including delivery of drug payloads to cells utilizing integrin receptor-binding molecules as tissue-specific delivery and internalization mechanisms. Currently, Pliant is conducting a Phase 1 study of PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that has shown encouraging clinical activity in the development of a treatment of immune checkpoint resistant solid tumors. 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.

Requirements

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

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