Associate Director, Program Management (Clinical)

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 Director, Program Management, the Associate Director, Program Management will drive clinical and cross-functional sub-team(s) forward in the development of medicines to target hypertension, CKD and other diseases driven by abnormally elevated aldosterone. The Associate Director will work in close collaboration with the Head of Program Management and Clinical Operations team to enable the execution of corporate strategy and goals.

A successful candidate will have program management experience, clinical operations experience, and a strong ability to function in an ambiguous and fast-paced work environment.

Key Responsibilities

• Oversee clinical projects with agile approach to ensure budget, scope and schedule are aligned with corporate priorities and objectives.
• Co-lead clinical study team meetings with the Clinical Trial Manager (CTM), ensure focus on key issues and risk mitigation, support decision making, prepare agendas and meeting minutes, and define/resolve action items.
• Lead sub-team meetings to review, track and coordinate project milestones and activities, as well as collaborate on and communicate program details, risks and mitigations. Ensure that all team members understand project goals, objectives and strategic value, the project plan/schedule, and critical path activities both at their individual/functional level as well as for the overall project.
• Build and manage clinical timelines in alignment with corporate strategy and corporate goals, including scenario planning and problem solving. Support the team in execution of the plan, and track progress.
• Proactively identify and escalate potential risks, issues, gaps and challenges. Collaborate with the cross functional team to identify mitigations, and drive resolution of issues and project impediments.
• Prepare project status updates and similar presentations for Management, including progress against plans, emerging issues, risks, and mitigations
• Collaborate with Finance and Clinical Operations to manage clinical study vendor budgets and resources
• Utilize a variety of project management tools, systems, software and techniques to support the development and scaling of high-performing teams and contribute to project management methodologies Serve as the regulatory lead for select clinical programs.

Qualifications

• BA/BS in life sciences
• A minimum of 5 years of experience in project management supporting mid-late stage clinical research projects in the biopharmaceutical industry
• Demonstrated deep knowledge of drug development including Clinical and Regulatory
• Experienced in regulatory submissions e.g., IND, CTA, NDA
• Proficient in various Project Management tools, software, systems, etc.
• Ability to establish processes in ambiguous environment
• Excellent organizational skills, detail-oriented & accurate
• Advanced analytical skills
• A team player with excellent interpersonal skills
• Motivated self-starter, strategic thinker, persistent, tactful, and persuasive
• Excellent written and oral communication skills
• Ability to handle multiple responsibilities, priorities, tasks, and projects simultaneously
• Ability to work under time pressure and effectively in a team or matrix environment