Associate Director, Program Management (CMC & Translational Medicine)

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

A successful candidate will have program management experience in the CMC and/or Translational Medicine experience, and a strong ability to function in an ambiguous and fast paced work environment.

Key Responsibilities

• Work closely with CMC and Translational Medicine teams to translate strategy into an executable plan
• Primary project management point of contact for all CMC and Translational Medicine projects
• Project Management lead for NDA CMC, Nonclinical & Clinical Pharmacology preparation team
• Ensure plans are aligned with KPIs and corporate strategy
• Ability to understand and communicate scientific and business elements with regards to CMC/ Translational Medicine plan
• Collaborates with cross functional team and vendors
• Ensure plan includes level of detail that allows teams to understand critical path activities
• Proactively identify and mitigate risks, and identify meaningful opportunities for acceleration
• Develop and manage timelines, scenario planning and generate visualizations to support decision making and strategic planning
• Ensure coordination of critical regulatory information and team communications to ensure timely and accurate dissemination of strategy and operational status
• Support Regulatory operational execution of major regulatory filings
• Facilitate process improvements and best practices
• Support budget and forecasting for the CMC and Translational Medicine functions

Qualifications

• Bachelors required, advanced degree preferred
• Minimum of 5 years industry experience
• 3 years CMC/ Clinical Pharmacology & Translational Medicine experience required
• Proficiency and demonstrated application of PM standards, planning and visualization methods/tools required i.e. Smartsheet
• Proven experience supporting/leading major FDA submissions desired
• Excellent interpersonal skills
• 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.