Associate Director, Clinical Quality Assurance
Pliant Therapeutics is a public, clinical 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 disease. The Company’s focus is on mechanism-based intervention in the fibrotic process using small molecules.
The Company’s lead product candidate, PLN-74809, is an oral, small molecule selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and are currently in Phase 2a clinical trials for these indications. The company recently reported positive data from its Phase 2a trial in IPF and is currently ramping up activities in preparation for a late-stage clinical trial at worldwide sites.
Pliant has also developed PLN-1474, a small molecule, selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant is initiating a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.
The Company is seeking passionate, creative, and dedicated individuals to join our team and contribute to our mission.
The Associate 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 Associate Director of CQA must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, 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.
- 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 SOPs where gaps are identified.
- Achieve assigned deliverables of the Clinical QA function.
- Conduct or provide support of GCP and GLP (e.g., central labs in support of clinical activities) 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 GCP auditors performing various GCP 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, GVP, and GLP (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 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.
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 8 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.
- 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 Pharmacovigilance Practice (GVP). Experience in GLP is a plus.
- 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 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 supporting regulatory 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.
- South San Francisco, California
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 $172,000 - $185,000. 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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