Associate Director, Clinical Operations

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.

Role Summary

Reporting to the Senior Vice President, Clinical Operations, the Associate Director, Clinical Operations is responsible for resourcing and performance management of Clinical Trial Associates, operational delivery of clinical trials and supporting the development and oversight of department goals and initiatives.

Key Responsibilities

• Manages Clinical Trial Associates with responsibility for recruitment,
• resourcing, training, performance management, employee goal setting and
• career development. May also manage contract staff.
• Supports execution of operational strategy (study scenario planning,
• operational decision points and risks, study timeline, study financials) for
• assigned program(s).
• Responsible for operational delivery of assigned clinical trials within program
• lifecycle, overseeing cross-functional alignment, budget, and timeline from
• protocol generation through completion of the clinical study report, ensuring
• quality and a focus on inspection readiness throughout.
• Proactively identifies study and program risks and implements contingency
• plans, providing regular updates on study status to Mineralys Leadership Team
• Participates in vendor identification and responsible for vendor set up and
• oversight.
• Active involvement in investigator identification and selection, including
• expansion to new geographies.
• Provides oversight of the development of study documentation, including
• clinical trial protocols, study plans and clinical study reports
• Participates in cross functional study data review.
• Supports development and oversight of departmental goals and objectives for
• Clinical Operations.
• Tracks key performance indicators and metrics for Clinical Operations and
• identifies opportunities to develop and optimize processes and procedures
• (e.g., SOPs, Work Instructions).
• Leads cross-functional initiatives.
• Contributes to building a culture of team, site and patient centricity.

Qualifications

• Bachelor's degree in life sciences discipline or related discipline
• Typically requires 12 years of experience executing clinical trials globally across all phases of development and 3 years of supervisory/management experience, or the equivalent combination of education and experience
• Demonstrates advanced project/program management skills including timeline and budget management, risk assessment and mitigation planning
• Proven track record of successfully overseeing staff to execute and deliver clinical trials on time and on budget, ensuring inspection readiness throughout
• Excellent understanding of GCP, CFR and ICH Guidelines
• Effective team leadership in cross-functional study and program teams, with demonstrated strength in team building
• Demonstrated ability to effectively interface successfully with external parties, including key personnel at investigational sites, Key Opinion Leaders, and vendors