pliant-therapeutic

Director, Toxicology

South San Francisco · Director · Full-time

Sponsorship not specified$232k-$256kDetected 71 days ago

ComplianceProject ManagementPharmacologyFDA RegulatoryResearchLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingRegulatory Affairs

About the role

Pliant Therapeutics is a clinical-stage biopharmaceutical company and leader in the discovery and development of novel integrin-based therapeutics.
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.
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.

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
Collaborates closely with internal cross-functional groups such as Pharmacology, ADME-PK, BA, CMC, Regulatory Affairs, Clinical Development, and Project Management
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
Our approach involves developing novel integrin-based therapeutics to treat solid tumors and other diseases.
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.
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
To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/.

Requirements

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.
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.)
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
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.
PhD in Toxicology, Biology, Pharmacology or related scientific discipline; Board certification (DABT) required
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

Compensation

The annual base salary for this role is $232,000 - $256,000.

Benefits

Pliant's compensation package also includes benefits, equity, and annual target bonus for fulltime positions.
Represents the organization in interactions with global health authorities, including preparation for and participation in agency meetings
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.
Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training.

Company info

Based in South San Francisco, California, Pliant was founded in 2015 to develop therapeutics to modulate specific pathways upregulated or dysfunctional in certain diseases.
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.
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.

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