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About the Role

The Vice President, Regulatory Affairs & Quality (GxP) will lead and oversee an integrated Regulatory and Quality function for Pliant's portfolio of programs, including its lead oncology program. This hands-on role involves owning day-to-day global regulatory and quality strategies and execution, overseeing a Quality team, and designing and scaling regulatory and quality infrastructure in GxP environments to support rapid, compliant execution of early phase clinical trials.

Responsibilities

Develops, owns, and executes Pliant's global regulatory strategy for oncology product candidates across the development lifecycle.
Leads the day-to-day preparation, review, and submission of regulatory filings, partnering closely with cross-functional teams.
Serves as primary agency contact (FDA and other health authorities) for regulatory interactions, fostering strong relationships.
Advises the executive team on oncology-specific regulatory pathways and designations and their strategic implications.
Keeps executive leadership apprised of the evolving regulatory landscape affecting oncology development.
Oversees and leads Pliant's Quality team, providing strategic direction and management of an integrated, risk-based Quality Management System (QMS).
Ensures quality policies, procedures, and a lean, fit-for-purpose suite of SOPs are in place and consistently followed.
Oversees a risk-based audit program for CROs, CMOs, clinical sites, and other third-party vendors.
Negotiates and manages quality agreements with CMOs, CROs, and other partners and suppliers.
Develops quality system metrics to proactively identify and address potential compliance risks.
Leads quality management and periodic dashboard reviews.
Serves as the key point of contact for managing and directing any regulatory or quality inspections.
Supports the pharmacovigilance and safety functions and provides regulatory and quality input into labeling, publications, and disclosures.
Provides critical evaluation of potential product and partnership opportunities for business development.
Owns departmental planning for the combined Regulatory and Quality organization, including structure, headcount, budgeting, and systems requirements.
Leads, coaches, and develops direct reports, fostering a collaborative, high-performing culture.
Manages relationships with external consultants and other third-party service providers.

Requirements

Bachelor's degree in a scientific field required; advanced degree (e.g., PhD, PharmD, MS) preferred.
15+ years of progressive, relevant experience in Regulatory Affairs and/or Quality within the biotech/pharmaceutical industry, including direct oncology drug development experience.
Minimum of 8+ years of leadership/management experience at a senior level, with direct accountability for team performance and development.
Demonstrated experience leading the preparation and submission of INDs/CTAs and other regulatory filings, with direct ownership of regulatory strategy for early-phase oncology assets.
Direct, hands-on experience serving as primary agency contact and leading interactions with FDA and other global health authorities.
Working knowledge of GLP, GCP, GVP and GMP requirements and practical experience implementing FDA and international regulations and guidance.
Experience with oncology-specific regulatory designations and expedited pathways.
Experience managing relationships with CROs and CMOs, including audits, quality agreements, and vendor oversight.
Proven ability to operate as both strategic advisor to the executive team and hands-on practitioner.
Excellent written and verbal communication skills across all levels of the organization and with external partners.
Ability to travel as needed (approximately 15–20% of time).

Skills

Regulatory Affairs
Quality Assurance
Oncology Drug Development
IND/CTA Submissions
FDA Interactions
Global Health Authority Interactions
GLP
GCP
GVP
GMP
Quality Management System (QMS)
Risk-based Audits
Quality Agreements
Vendor Oversight
Strategic Planning
Team Leadership
Communication Skills

Location

South San Francisco

Work Type

Hybrid

Experience Level

15+ years of experience
8+ years of leadership/management experience

Education Level

Bachelor's degree in a scientific field
Advanced degree (e.g., PhD, PharmD, MS) preferred

Salary/Compensations

$351K – $388K

Benefits

Equity
Annual target bonus

About the Company

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 dare to succeed, are committed to making an important impact on patient’s lives and will help us build one Pliant!

Equal Opportunity

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/.