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. Pliant’s second product candidate, PLN-1474, is an oral, small molecule selective inhibitor of the αvβ1 integrin, in development as a potential treatment for late-stage liver fibrosis under a partnership with Novartis. 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.
Description
The Senior Director of 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 is a hybrid position, with a 3 day in the office expectation (South San Francisco). This position will be reporting to Sr. VP Development Operations.
The Clinical QA Director 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 conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, and program recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Responsibilities
- Accountable for deliverables of the Clinical QA function.
- Accountable for continuous monitoring and risk assessments in the clinical QA audit program.
- Accountable for conduct 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.
- Accountable for development and implementation of internal standards, policies, and procedures to ensure compliance
- Responsible for functional & operational leadership to a team of GCP auditors, performing the different GCP audit types.
- Responsible for setting operational objectives for the team to ensures alignment with company, project team, departmental objectives.
- Responsible for development and implementation of audit plans and annual audit schedules.
- Serve as a member of internal study management teams to provide compliance advice and guidance to achieve continuous quality improvement and effective quality assurance.
- Interface with Pliant functional areas, including regulatory, clinical, and development sub-teams, as appropriate to provide guidance, interpretation, and information on regulations, standards, and quality systems.
- Participate in the evaluation and selection of Clinical Service Providers for GCP, GVP, GLP activities, as well as other service providers, e.g., audit consultants.
- Plan and oversee clinical investigator site audits to determine compliance status and identify compliance risks. Upon audit completion, communicate results to the relevant stakeholders and ensure corrective and preventative actions (CAPA) are completed.
- Support quality event management for assigned clinical programs and/or studies, including assessment of potential root causes and CAPA.
- Identify and assess GCP, GVP, and GLP (as pertaining to conduct of clinical trials) compliance risk areas (internal and external) by recommending resolutions, developing, and implementing risk mitigation measures. Ensure compliance with Quality objectives, policies, procedures, and escalate risks to Sr. Management as appropriate.
- Collaborate with QA-GMP function to build integrated quality systems.
- Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, PV/Safety, CROs and clinical sites to ensure 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 12 years of experience in Clinical QA, with at least 3-5 years leading the GCP function.
- At least 2 years managing direct reports.
- Broad knowledge of risk-based quality systems approaches consistent with ICH E6 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 auditing clinical CRO’s, clinical sites, and investigator sites.
- 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.
The annual base salary for this role is $235,000 - $265,000. 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.
To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/.
