Vice President, Regulatory Affairs and Quality (GxP)

Role: Vice President, Regulatory Affairs & Quality leading global regulatory strategy and GxP quality operations for Pliant's oncology portfolio, including Phase 1b programs. Responsibilities: develop and execute regulatory strategies, lead regulatory filings (INDs/CTAs), serve as primary agency contact, advise on regulatory pathways, oversee Quality management systems across GLP, GCP, GVP, GMP environments, manage audits, vendor relationships, and inspections, and support safety and business development activities. Requirements: Bachelor's in a scientific field; 15+ years in biotech/pharma Regulatory Affairs and/or Quality with oncology drug experience; 8+ years of senior leadership and team management; hands-on regulatory submission and agency interaction experience; knowledge of GxP regulations, expedited pathways (e.g., Breakthrough Therapy), and vendor oversight. Preferred: experience with small molecules/targeted therapies, scaling regulatory/quality functions, and transitioning from Phase 1b/2 to late-stage development. HighValue: oncology, Phase 1b, IND/CTA filings, FDA interactions, GxP compliance, regulatory pathway strategy, vendor management, hybrid onsite (South San Francisco), with some travel.