Mineralys is seeking a Director/Sr. Director, Medical Excellence Operations to be a critical partner in building and scaling the Medical Affairs function. This role supports both operational execution and long-range planning, ensuring the team has the structure, processes, and tools necessary for success.
What You'll Do
- Provide operational support for the Field Medical team, including coordination of equipment, onboarding, offboarding, and resource management.
- Lead onboarding, training, and ongoing education processes for Medical Science Liaisons to ensure readiness and compliance.
- Track, coordinate, and maintain documentation for Investigator-Initiated Studies (IIS).
- Serve as the primary liaison with IT for communication, troubleshooting, and support for all Medical team members.
- Manage and optimize medical systems, including Veeva, data repositories, reporting tools, and documentation platforms.
- Build and maintain infrastructure for medical activities like publication planning, insights management, and scientific engagement tracking.
- Develop, implement, and maintain SOPs and operational processes for contract management, publication planning, materials review, and insights capture.
- Coordinate Fair Market Value (FMV) assessments and ensure compliant documentation.
- Partner with Compliance to embed best practices and maintain audit-ready documentation.
- Support creation of 1-year and 5-year operational plans for Medical Affairs, including resource planning and systems roadmaps.
- Contribute to annual budget development and ongoing budget management, including spend visibility and vendor oversight.
- Establish and track Key Performance Indicators (KPIs) to measure Medical Affairs effectiveness, field performance, and operational efficiency.
- Streamline processes for advisory boards, medical symposia, congress activities, and scientific meetings.
- Work closely with Clinical Development, Commercial, IT, Legal, and Compliance to ensure alignment and continuous improvement.
What We're Looking For
- Bachelor’s degree required in life sciences.
- 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.
- 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.
- Ability to travel approximately 20%, including overnight travel for meetings and planning sessions.
Nice to Have
- Advanced degree preferred.
Technical Stack
- Veeva
- Data repositories
- Reporting tools
- Documentation platforms
Team & Environment
This role supports the Medical Affairs function, particularly the Field Medical team, and works closely with Clinical Development, Commercial, IT, Legal, and Compliance.
Benefits & Compensation
- Medical, dental, vision insurance
- Time off
- 401K
- Participation in Mineralys incentive plans contingent on achievement of personal and company performance
- Compensation range: $220,000 - $260,000
Work Mode
This is a US Remote position.
Mineralys is an equal opportunity employer.
