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Mineralys Therapeutics, Inc. · 18 hours ago

Director/Sr. Director, Medical Excellence Operations

United States

Full-time

Remote

Director/Executive

$220K/yr - $260K/yr

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The Medical Excellence Operational Lead will support operational execution and long-range planning for the Medical Affairs function, ensuring the Field Medical team has the necessary structure, processes, systems, and tools for success.

BiopharmaBiotechnologyMedicalPharmaceutical

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)

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 Key Performance Indicators (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

Qualification

Medical affairs operationsVeeva systemsPublication planningAnalytical skillsProject managementCommunication skillsOrganizational skillsCross-functional collaboration