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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 hire 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.
Seniority level
Director
Employment type
Full-time
Job function
Research
Industries
Biotechnology Research
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