Pliant Therapeutics
We are transforming the lives of patients by developing best-in-class treatments for fibrotic diseases.
fibrosis • integrins • muscle biology • oncology • Duchenne muscular dystrophy
51 - 200
Director, Clinical Quality Assurance
August 1
🏢 In-office - San Francisco
Pliant Therapeutics
We are transforming the lives of patients by developing best-in-class treatments for fibrotic diseases.
fibrosis • integrins • muscle biology • oncology • Duchenne muscular dystrophy
51 - 200
Description
• Responsible for ensuring clinical trials adhere to GCP regulations and guidelines. • Support clinical compliance and inspection readiness. • Provide quality oversight of clinical programs. • Collaborate with Clinical Development, Regulatory Affairs, and CROs.
Requirements
• Bachelor’s degree with 12 years’ experience required or advanced degree in a scientific field with 10 years’ experience preferred. Quality assurance professional certification is a plus. • At least 5 years of experience in Clinical Quality Assurance or Clinical Operations. • Broad knowledge of risk-based quality systems approaches consistent with ICH E6 (R2) for Good Clinical Practice. Experience with all phases of clinical trials. • Knowledge and practical application of ICH E8 (R1) • Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines including understanding and application of domestic and international regulatory requirements. • Previous experience of Good Clinical Practice (GCP), and Good Clinical Laboratory Practice (GCLP). • Knowledge and experience implementing phase appropriate procedures and processes and familiarity with data integrity controls. • Experience interacting with domestic and international clinical service providers for early phase to late-stage clinical trials. • Proven history of industry success including experience in regulatory inspection preparation and supporting inspections. • Experience with the audit process, auditing clinical sites, and auditing clinical service providers is preferred. • Experience with Pre Approval Inspection readiness activities such as creating story boards, inspection electronic management systems, mock inspection, etc., including, clinical study site preparation. • Clinical Quality Auditor certificate is a plus. • Some travel may be required. • Ability to operate in alignment with Pliant’s values and culture.
Benefits
• Equity • Annual target bonus for fulltime positions • Comprehensive benefits package
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