Director/Sr. Director, Medical Excellence Operations

Role Summary

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.

Responsibilities

• 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.
• 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.
• 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); and 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.
• 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 KPIs to measure Medical Affairs effectiveness, field performance, insights generation, scientific engagement, operational efficiency, and compliance adherence.
• 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.

Skills

• Operational excellence in medical affairs and field medical operations
• Cross-functional collaboration and stakeholder management
• Process improvement and governance
• Data systems management and analytics
• Regulatory and compliance awareness

Education

• Bachelor’s degree in life sciences; advanced degree preferred

Additional Requirements

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