Sr. Manager/Associate Director, Clinical Quality Assurance
Pliant Therapeutics is a 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 for progress to meet unmet medical needs for patients and physicians. 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 designed to be a selective inhibitor of 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), has completed Phase 1b testing. Pliant’s second product candidate, PLN-1474, is designed to be an oral, small molecule selective inhibitor of αvβ1, targeting late-stage liver fibrosis and is partnered with Novartis. The company is seeking passionate, creative, and dedicated individuals to join our team and contribute to our mission.
The Sr. Manager/Associate Director, Clinical Quality Assurance (CQA) is a hands-on position responsible for all 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 monitor clinical compliance and inspection readiness. This position will be reporting to Director, QA.
- Develop, update, and maintain GCP governance and procedures such as SOPs, policies, and work instructions to ensure compliance with 21 CFR Parts 50, 56 and 312, ICH E6 and relevant regulatory guidance documents.
- Perform ongoing monitoring and risk assessments in the clinical QA audit program. Develop and implement audit plans and annual audit schedules. Conduct 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.
- Identify and assess quality and compliance risk areas by recommending resolutions, developing, and implementing risk mitigation measures. Ensure compliance with Quality objectives, policies, procedures, and escalate risks to Sr. Management as appropriate.
- Review and approve essential clinical documents (e.g., protocols, informed consents, investigator brochures, clinical study reports, pharmacy manual, etc.).
- Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, PV/Safety, CROs and clinical sites to ensure overall GCP compliance and inspection readiness.
- Provide leadership to Pliant Clinical Operations, clinical sites, and CROs in preparations for BIMO inspections and inspections by other regulatory authorities. Respond to and resolve issues relating to inspection findings.
- Provide Clinical QA guidance to internal clinical study teams. Maintain knowledge of current regulatory requirements and inform Pliant stakeholders of potential impact on the organization.
- Conduct training to functional areas as required.
- Develop, track, and report key Clinical QA metrics.
- Bachelor’s Degree in a scientific or related discipline with advanced degree preferred.
- 7+ years of experience in a CQA role, with at least 3-5 years leading the GCP function.
- Comprehensive knowledge of and ability to interpret and apply EU, FDA and ICH regulations and guidance documents.
- Experience in clinical trials with small molecules highly preferred.
- Experience with hosting or participating in regulatory inspections and mock inspection readiness planning and execution.
- Experience in GCP and GLP audits either through performing audits or being the recipient of the audit.
- Experience with Quality Systems (e.g., SOPs, audits deviations, investigations and CAPA programs).
- Experience in GLP and/or GVP is a plus.
- Experienced with EDC, IRT, and eTMF systems.
- Ability to make appropriate risk-based assessments and decisions based on phase-specific requirements.
- 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.
- Demonstrated leadership in cross-functional and culturally diverse team settings.
- Travel as needed.
- Accuracy and attention to detail.
- Solution oriented with good problem-solving skills.
- Excellent verbal, written, interpersonal, team collaboration, and communication skills are necessary with the ability to influence individual and teams across Pliant organization.
- Ability to build and manage relationships with external partners.
- Ability to work independently in a fast-paced environment with minimal directions under compressed deadlines, and effectively organize, prioritize, and manage multiple projects (multi-task).
- Proficient in MS Word, Excel, Power Point, and other applications.