Director, Clinical Quality Assurance - San Francisco, CA, United States - Pliant Therapeutics, Inc.

Description

Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.

The Company's lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the ?v?1 and ?v?6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b trial of bexotegrast for the treatment of IPF and INTEGRIS-PSC, a Phase 2a trial of bexotegrast for the treatment of PSC.

Pliant has also developed PLN-1474, a small molecule, selective inhibitor of ?v1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of ?v8 and ?v1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.

Description

The Director of Clinical Quality Assurance (CQA) is a hands-on position responsible for all assigned activities that ensure Pliant Therapeutics sponsored clinical trials adhered to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Pliant Standard Operating Procedures (SOPs), and current industry standards and practices. The candidate will support clinical compliance and inspection readiness. This position will be reporting to Senior Director, CQA.

The Director of CQA must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, effective, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good negotiation skills, ability to analyze issues to support relevant and realistic plans, and support program recommendations. Demonstrated ability to support strategic and tactical decisions into action; excellent analytical skills, and to support plans to resolve issues and mitigate risks.

Responsibilities

Support managing a risk-based clinical Quality Management System (QMS) for GCP QA in compliance with applicable regulatory requirements (US and OUS), and company policies.

Author and review Standard Operating Procedures through gap analysis.

Continue to foster Plaints' culture of continuous improvement with emphasis on efficiency and effectiveness.

Achieve assigned deliverables of the Clinical QA function.

Conduct or provide support of GCP, GCLP, GLP, and GVP audits of clinical investigator sites, Contract Research Organizations (CROs), contract clinical laboratories, and processes/systems to determine compliance status.

Responsible for oversight of the completion of corrective and preventative actions (CAPA) upon audit completion.

Responsible for implementation of internal standards, policies, and procedures to ensure compliance.

Support contract GXP auditors performing various GXP audit types.

Support development and implementation of audit plans and annual audit schedules.

Provide compliance advice and guidance to achieve continuous quality improvement and effective quality assurance.

Interface with Pliant functional areas, including regulatory affairs, and development operations, as appropriate, to provide guidance, interpretation, and information on regulations, standards, and quality systems.

Support quality event management for assigned clinical programs and/or studies, including assessment of potential root causes and CAPA.

Support the identification of GCP, GCLP, GLP, and GVP (as pertaining to conduct of clinical trials) compliance risk areas (internal and external) and support the resolution, development, and implementation of risk mitigation measures. Ensure compliance with Quality objectives, policies, and procedures.

Responsible for GCP training to include development and revision of training matrices and training new GCP personnel.

Responsible for TMF compliance oversight for all studies.

Collaborate with Clinical Development (including PV/Safety), Regulatory Affairs, and Development Operations (including Clinical Operations, Data Management, and Biostatistics), CROs and clinical sites to support overall GCP compliance and inspection readiness.

Qualifications

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.

Bachelor's degree required, advanced degree in a scientific field preferred. Quality assurance professional certification is a plus.

At least 10 years of experience in Clinical Quality Assurance.

Broad knowledge of risk-based quality systems approaches consistent with ICH E6 (R2) and proposed (R3) for Good Clinical Practice. Experience with all phases of clinical trials.

Knowledge and practical application of ICH E8 (R1)

In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines.

Previous experience of Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP).

Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.

Experience with the audit process, auditing clinical sites, and auditing clinical service providers.

Familiarity with data integrity controls, experience in system validation is a plus.

Understanding and application of domestic and international regulatory requirements.

Proven track record of industry success including experience in regulatory inspection preparation and supporting inspections.

In-depth knowledge and experience implementing phase appropriate procedures and processes.

Experience interacting with domestic and international clinical service providers for early phase to late-stage clinical trials.

Clinical Quality Auditor certificate is a plus.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $220,000 - $230,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant's compensation package also includes benefits, equity, and annual target bonus for fulltime positions.

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