Associate Director, Program Management (Regulatory 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 Director, Program Management, the Associate Director, Program Management will help drive Regulatory projects and cross-functional sub-teams forward in the development of medicines to target hypertension, CKD and other diseases driven by abnormally elevated aldosterone. The AD, Program Management will work in close collaboration with the Head of Program Management and Head of Regulatory to enable the execution of corporate strategy and goals.

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

Key Responsibilities

• Primary project management point of contact for all Regulatory plans
• Ensure Regulatory plans are aligned with KPIs and corporate strategy
• Will collaborate with PM, ClinOps, CMC, Medical writing, and other key functions
• Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand with is critical at any time
• Proactively identify and mitigate regulatory risks, and exploit meaningful opportunities for acceleration
• Driving processes to optimize global filing and launch sequencing, pre and post submission activities, preparation for health authority meetings and additional regulatory milestones
• Manage timelines, scenario plan and generate visualizations to support decision making and strategic planning
• Ensure coordination of critical reg information and team communications to ensure timely and accurate dissemination of strategy and operational status
• Support Regulatory operational execution of major regulatory filings
• Drive Regulatory process improvements and best practices
• Support budget and forecasting for the regulatory function
• Project Management lead NDA preparation team

Qualifications

• Bachelors required, advanced degree preferred
• Minimum of 5 years industry experience
• 3 years Reg Ops/ Reg PM experience required
• Proficiency and demonstrated application of PM standards, planning and visualization methods/tools required
• Knowledge of global regulations, guidelines and regulatory requirements with in depth knowledge/focus of FDA/EMA procedures is required
• Proven experience supporting/leading major FDA submissions (NDA) desired
• Ability to establish processes in ambiguous environment
• Good organizational skills, detail-oriented & accurate
• Advanced analytical skills
• Must be a team player
• Motivated self-starter, strategic thinker, persistent, tactful, and persuasive
• Excellent communication and interpersonal 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

This position requires up to 20 % travel. Frequently travel is outside the local area and overnight. Some of the travel may be international.