Head of Clinical Quality Assurance

2 weeks ago

South San Francisco, California, United States Pliant Therapeutics Full time

Pliant Therapeutics is a leading biopharmaceutical organization dedicated to the innovation and advancement of groundbreaking treatments for fibrotic diseases. Established by Third Rock Ventures alongside esteemed academic experts, Pliant is committed to addressing the critical medical needs of healthcare providers, patients, and families affected by fibrotic conditions. As a pioneer in the research and development of novel therapeutic agents for fibrotic diseases, Pliant is focused on creating small molecule drug candidates specifically engineered to target the fibrotic process.

The Company's flagship product candidate, bexotegrast (PLN-74809), is an oral small molecule that selectively inhibits the αvβ1 and αvβ6 integrins, which are integral to various fibrotic pathways. Bexotegrast has been granted Fast Track Designation and Orphan Drug Designation by the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC), as well as Orphan Drug Designation from the European Medicines Agency for IPF and PSC. Pliant is actively conducting BEACON-IPF, a Phase 2b/3 clinical trial of bexotegrast for the treatment of IPF.

Pliant is also undertaking a Phase 1 study for its third clinical initiative, PLN-101095, a small molecule that acts as a dual-selective inhibitor of αvß8 and αvß1 integrins, which is being developed for the treatment of solid tumors. The Company has additional discovery and development programs in oncology and muscular dystrophies.

Position Overview

The Director of Clinical Quality Assurance (CQA) is a pivotal role responsible for ensuring that clinical trials sponsored by Pliant Therapeutics comply with relevant Good Clinical Practice (GCP) regulations (including FDA, international, and country-specific guidelines), ICH standards, Pliant Standard Operating Procedures (SOPs), and contemporary industry practices. The selected candidate will play a crucial role in supporting clinical compliance and maintaining inspection readiness. This position reports directly to the Senior Director of CQA.

The Director of CQA must excel in a dynamic, innovative setting while demonstrating flexibility, proactivity, resourcefulness, effectiveness, and efficiency. Exceptional interpersonal skills, the ability to cultivate significant relationships with key stakeholders, strong negotiation abilities, and the capacity to analyze challenges to develop relevant and practical plans are essential. The role requires a demonstrated ability to translate strategic and tactical decisions into actionable steps, along with excellent analytical skills to support plans aimed at resolving issues and mitigating risks.

This is a hybrid role, necessitating in-office presence at Pliant for three days each week.
Key Responsibilities

  • Act as the representative for clinical quality in program team meetings, providing operational quality guidance to development teams.
  • Serve as the clinical quality representative in operational meetings with CROs, service providers, and vendor quality meetings.
  • Oversee the quality of ongoing clinical programs, ensuring that proper assessments, monitoring, risk evaluations, and mitigation strategies are implemented.
  • Review clinical trial documentation to ensure data integrity and compliance with GCP and regulatory standards, including key clinical and IND/NDA enabling documents.
  • Provide clinical quality support during Health Authority Inspections, as well as during operational meetings with service providers and CROs, and contribute to inspection readiness activities.
  • Collaborate with Clinical Development (including Pharmacovigilance/Safety), Regulatory Affairs, and Development Operations (including Clinical Operations, Data Management, and Biostatistics), CROs, and clinical sites to uphold GCP compliance and inspection readiness.
  • Assist in managing a risk-based clinical Quality Management System (QMS) for GCP QA in alignment with applicable regulatory requirements (both US and international) and company policies.
  • Offer compliance guidance to foster continuous quality improvement and effective quality assurance, while promoting Pliant's culture of ongoing enhancement with a focus on efficiency and effectiveness.
  • Support the establishment of internal standards, policies, and procedures to ensure compliance, including co-authoring and reviewing Standard Operating Procedures.
  • Develop and implement study-specific audit plans and annual audit schedules, along with periodic compliance and metric reports.
  • Assist in the selection of clinical service providers and qualification activities.
  • Manage quality event oversight for assigned clinical programs and/or studies, including root cause assessments and corrective and preventative actions (CAPA). Aid in the supervision of corrective and preventative actions (CAPA) following audit completion.
  • Responsible for GCP training, including the development and revision of training matrices and onboarding new GCP personnel.
  • Conduct or assist in GCP, GCLP, GLP, and GVP audits of clinical investigator sites, Contract Research Organizations (CROs), contract clinical laboratories, and processes/systems to assess compliance status. This includes supporting contract GXP auditors in various GXP audit types.
Qualifications

To be successful in this role, candidates must possess the ability to perform each essential duty effectively. The qualifications listed below are representative of the knowledge, skills, abilities, and prior experience required:
  • Bachelor's degree with a minimum of 12 years of experience required, or an advanced degree in a scientific discipline with at least 10 years of experience preferred. Quality assurance professional certification is advantageous.
  • A minimum of 5 years of experience in Clinical Quality Assurance or Clinical Operations.
  • Comprehensive knowledge of risk-based quality systems approaches consistent with ICH E6 (R2) for Good Clinical Practice, with experience across all phases of clinical trials.
  • Understanding and practical application of ICH E8 (R1).
  • Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines, including a solid understanding of domestic and international regulatory requirements.
  • Prior experience with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP).
  • Familiarity with implementing phase-appropriate procedures and processes, as well as knowledge of data integrity controls.
  • Experience in engaging with domestic and international clinical service providers for early-phase to late-stage clinical trials.
  • Proven track record of success in the industry, including experience in regulatory inspection preparation and support.
  • Experience with the audit process, including auditing clinical sites and clinical service providers, is preferred.
  • Familiarity with Pre-Approval Inspection readiness activities, such as creating storyboards, managing inspection electronic systems, conducting mock inspections, etc., including preparation for clinical study sites.
  • Clinical Quality Auditor certification is a plus.
  • Some travel may be necessary.
  • Ability to align with Pliant's values and organizational culture.
Pliant requires all new hires to be fully vaccinated prior to the commencement of employment (subject to any legally mandated exemptions).

The annual base salary for this position ranges from $230K to $240K. Individual compensation may vary based on additional factors, including, but not limited to, job-related skills, experience, work location, and relevant education or training. Pliant's compensation package also includes benefits, equity, and an annual target bonus for full-time positions.

For information on how Pliant manages personal information in accordance with the California Consumer Privacy Act, please visit our website.

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