Director/Sr. Director, Medical Excellence Operations

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone.  Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor.  Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky”

Mineralys is a fully remote company.

The Medical Excellence Operational Lead will be a critical partner in building and scaling the Medical Affairs function at Mineralys. This role supports both operational execution and long-range planning, ensuring Medical Affairs—particularly the Field Medical team—has the structure, processes, systems, and tools necessary for success. The ideal candidate brings a strong background in medical operations, systems management, compliance, and cross-functional coordination, along with the ability to drive process improvement and operational rigor in a growing organization.

Key Responsibilities

Field Medical & Medical Affairs Operations

• Provide operational support for the Field Medical team, including coordination of equipment, company vehicles, onboarding, offboarding, and resource management.
• Lead onboarding, training, and ongoing education processes for Medical Science Liaisons to ensure consistent readiness, compliance, and scientific alignment.
• Track, coordinate, and maintain documentation for Investigator-Initiated Studies (IIS), ensuring compliance with internal procedures and external regulations.

Systems, Data, and Infrastructure

• Serve as the primary liaison with IT, ensuring efficient communication, troubleshooting, and support for all Medical team members.
• Manage and optimize medical systems—including Veeva, data repositories, reporting tools, and documentation platforms—to support accuracy, compliance, and operational scalability.
• Build and maintain infrastructure for medical activities, including publication planning systems, insights management, and scientific engagement tracking.

 Process, Policy, and Compliance Excellence

• Develop, implement, and maintain SOPs and operational processes related to:
  • Contract management for HCP engagements, vendors, and service providers
  • Publication planning and execution
  • Review of advertising and promotional materials (in partnership with Compliance/Legal)
  • Insights capture, governance, and performance measurement
• Coordinate Fair Market Value (FMV) assessments and ensure documentation is compliant with internal guidelines.
• Partner with Compliance to embed best practices and maintain audit-ready documentation across all Medical teams.

Strategic Planning & Department Performance

• Support creation of 1-year and 5-year operational plans for the Medical Affairs function, including resource planning, systems roadmaps, and capability development.
• Contribute to annual budget development and ongoing budget management, ensuring visibility into spend, forecasting, and vendor oversight.
• Establish and track Key Performance Indicators (KPIs) to measure Medical Affairs effectiveness, field performance, insights generation, scientific engagement, operational efficiency, and compliance adherence.

Cross-Functional Collaboration & Meeting Management

• Streamline processes for advisory boards, medical symposia, congress activities, and scientific meetings—including logistics, vendor coordination, contracting, compliance workflow, and post-event deliverables.
• Work closely with Clinical Development, Commercial, IT, Legal, and Compliance to ensure alignment, transparency, and continuous improvement across all Medical operations.

Qualifications

• Education: Bachelor’s degree required in life sciences; advanced degree preferred.
• Experience in medical affairs operations within a biotechnology or pharmaceutical company.
• Knowledge of Veeva systems, FMV processes, MSL operations, publication planning workflows, and medical compliance requirements.
• Skills:
  • Exceptional organizational, communication, and project management capabilities.
  • Strong analytical skills with experience supporting dashboards, KPIs, and operational reporting.
  • Ability to work independently in a fully remote environment, manage multiple priorities, and introduce scalable processes.
  • Demonstrated ability to collaborate cross-functionally and influence without authority in a fast-paced, growth-stage company.

 

Travel approximately 20%, including overnight travel for Medical Affairs planning sessions, company meetings and cross-functional onsite meetings.

These positions are eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.

US Salary Range:  $220, 000 - $260,000

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