Director, Clinical Compliance

Mineralys Therapeutics (Nasdaq: MLYS) is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Lorundrostat, our flagship program, is a best-in-class aldosterone synthase inhibitor, poised to redefine treatment paradigms for hypertension, chronic kidney disease, and other cardiorenal diseases. In our fast-paced, agile, and collegial culture, we are committed to excellence, collaboration, and innovation in everything we do, aiming for improved patient care.

Director, Clinical Compliance

Reporting to the Senior Vice President, Clinical Operations, the Director, Clinical Compliance is responsible for leading all Clinical Operations functions in training, process management and support inspection readiness activities in collaboration with Quality Assurance.

Key Responsibilities

Oversee the management and deployment of operational training programs, inclusive of:

• Content development and deployment of new hires and ongoing GCP training
• Create Clinical documents training matrix in collaboration with functional area heads as applicable for operational roles
• Development, and delivery of standards for learning programs
• Development, monitoring and reporting of Key Performance Indicators (KPIs) for training compliance and effectiveness.

Serve as the Clinical Operations Audit/ Inspection Lead inclusive of the following tasks:

• Ongoing development and support of audits and inspection readiness activities/materials for Clinical Operations
• Training and preparation of Subject Matter Experts (SMEs)
• Risk identification and proposal of follow up remediation strategies with applicable SMEs
• Participate in the implementation of mock inspection exercises in collaboration with Quality Assurance (QA) Team
• Provide guidance for the development of storyboards
• Oversee the timely and adequate development of Corrective and Preventive Actions (CAPAs) to audits and regulatory inspection findings as necessary
• Ensure audits and inspections findings are remediated and processes are implemented within Clinical Operations as committed to regulatory authorities
• Provide Lessons Learned after each audit and GCP inspection to the Clinical Operational Teams
• Provide and educate Clinical Operations teams on the Quality Indicators as provided by QA for Inspection outcomes

Serve as the Primary Audit Liaison for internal process audits in collaboration with the applicable Functional Area Lead

• Assist Clinical Operations in the development of CAPA plans and investigations in response to audits
• Monitor and report KPIs for Audits findings and CAPA responses

Serve as the Primary Clinical Operational Lead for process development and continuous improvements in collaboration with the Associate Director, Process Development and Improvement:

• Ensure accuracy and consistency in processes throughout Clinical Operations
• Develop and oversee the implementation of methods for continuous process improvement
• Develop, monitor and report KPIs as applicable related to process development and ongoing continuous improvement activities by Clinical Operations.

Serve as the Lead for Clinical Operations for all quality response activities, inclusive of:

• Quality Issue investigations and CAPAs
• Protocol and GCP deviation
• Serious Breaches
• Privacy Issues
• Develop, monitor and report KPIs as related to the above

Qualifications

• BS/BA degree in a life sciences discipline required.
• 10+ years of experience working in the biopharmaceutical industry.
• Advanced understanding of GCP, FDA CFR, UK Statutory Instruments, EU Directives, and ICH guidelines
• Strong Project Management skills
• Experience in the development and monitoring of metrics and KPIs
• Significant experience participating in clinical quality activities and in-depth knowledge of clinical operations
• Possess strong critical thinking skills with a focus on inspection readiness.
• Significant experience with investigations, root cause analysis and corrective action and preventive action plan development.
• Demonstrated attention to detail, accuracy, excellent review and analytical skills
• Results oriented
• Significant experience with guiding and coaching employees
• Excellent interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team
• Excellent written and oral communication skills and presentation skills.

This position requires up to 10% travel.