Vice President, Regulatory Affairs and Quality (GxP)

<div class="content-intro"><p>At Pliant, we believe differentiated science can make a meaningful impact. We see our success as a direct result of the central role that each team member plays in advancing our mission to develop therapies that target the disease at its source. We are seeking creative, curious and collaborative individuals who <strong>dare to succeed</strong>, are committed to <strong>making an important impact</strong> on patient’s lives and will help us build <strong>one Pliant</strong>!</p></div><h1><strong>Description</strong></h1> <p>Reporting to the Chief Operating Officer, the Vice President, Regulatory Affairs & Quality (GxP) will lead and oversee an integrated Regulatory and Quality function for our portfolio of programs, including our lead oncology program currently in Phase 1b. This is a hands-on role for a leader who will own day-to-day global regulatory and quality strategies and execution, and also oversee a Quality team and its deliverables. The successful candidate will design and scale right-sized regulatory and quality infrastructure in GxP environments (including and not limited to clinical, manufacturing, and laboratories) that supports rapid, compliant execution of early phase clinical trials, while laying the foundation for later-stage and eventual commercial readiness, as appropriate.</p> <p>This individual will serve as Pliant's primary interface with the FDA and other global health authorities for both regulatory strategy and inspection readiness, and will be accountable for ensuring the company's portfolio pipeline is developed in full compliance with applicable regulations while maintaining the speed and flexibility required of a clinical-stage biotech.</p> <p>This is a hybrid position, 3 days/week onsite (South San Francisco).</p> <h1><strong>Responsibilities</strong></h1> <ul> <li>Develops, owns, and executes Pliant's global regulatory strategy for oncology product candidates across the development lifecycle, from IND/CTA through proof-of-concept and planning for pivotal development.</li> <li>Leads the day-to-day preparation, review, and submission of regulatory filings — including INDs/CTAs, protocols, and briefing documents — partnering closely with clinical development, CMC, biometrics, and translational teams.</li> <li>Serves as primary agency contact (FDA and other health authorities) for regulatory interactions, including pre-IND, End-of-Phase 1/2, and other milestone meetings, fostering strong relationships and acting as a credible, effective advocate for the company.</li> <li>Advises the executive team on oncology-specific regulatory pathways and designations (e.g., Fast Track, Breakthrough Therapy, Orphan Drug, Accelerated Approval) and their strategic implications for trial design and sequencing.</li> <li>Keeps executive leadership apprised of the evolving regulatory landscape affecting oncology development and provides tactical direction to ensure cross-functional consistency in regulatory approach.</li> <li>Oversees and leads Pliant's Quality team, providing strategic direction and management of an integrated, risk-based Quality Management System (QMS) covering GLP, GCP, GVP and GMP appropriate to a Phase 1/2 development-stage organization.</li> <li>Ensures quality policies, procedures, and a lean, fit-for-purpose suite of SOPs are in place, understood, and consistently followed to support IND-enabling studies, clinical trial conduct, and investigational product manufacturing and release.</li> <li>Oversees a risk-based audit program for CROs, CMOs, clinical sites, and other third-party vendors supporting the oncology pipeline.</li> <li>Negotiates and manages quality agreements with CMOs, CROs, and other partners and suppliers.</li> <li>Develops quality system metrics to proactively identify and address potential compliance risks before they affect trial timelines.</li> <li>Leads quality management and periodic dashboard reviews and ensures no significant disruption to development activities due to quality or compliance issues.</li> <li>Serves as the key point of contact for managing and directing any regulatory or quality inspections.</li> <li>Supports the pharmacovigilance and safety functions as an active member of the safety governance and review team, and provides regulatory and quality input into labeling, publications, and investor/legal disclosures related to clinical and nonclinical data, as applicable.</li> <li>Provides critical evaluation of potential product and partnership opportunities in support of business development and licensing activities.</li> <li>Owns departmental planning for the combined Regulatory and Quality organization — including structure, headcount, budgeting, and systems requirements — scaling in step with pipeline maturity and organizational growth.</li> <li>Leads, coaches, and develops direct reports, fostering a collaborative, high-performing culture appropriate to the company's stage of growth.</li> <li>Manages relationships with external consultants and other third-party service providers (i.e. CROs), including determining when and how to engage outside support as the organization scales.</li> </ul> <h1><strong>Qualifications</strong></h1> <p>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.</p> <ul> <li>Bachelor's degree in a scientific field required; advanced degree (e.g., PhD, PharmD, MS) preferred.</li> <