Associate Director - Compliance

Key Responsibilities

• Partner with compliance lead to build, refine, and continuously mature a best-in-class compliance program aligned with OIG guidance, industry standards and best practices, and Mineralys’ strategic priorities
• Draft, implement, and periodically refresh compliance policies, standard operating procedures, and related guidance documents
• Manage the end-to-end policy lifecycle, including stakeholder review and communication of policy updates to affected personnel
• Design, develop, and administer a comprehensive compliance training program that supports ongoing education and reinforces a strong compliance culture
• Partner with business to manage Mineralys’ healthcare professional (HCP) engagement program
• Evaluate proposed HCP engagements for legitimate business need, appropriate fair market value (FMV) compensation, and consistency with legal and regulatory requirements
• Implement a risk-based compliance monitoring program that evaluates adherence to policies and procedures across high-risk business activities
• Support the management and resolution of compliance investigations ensuring timely, consistent, and well-documented outcomes
• Take on strategic compliance projects and initiatives, including support for privacy matters
• Perform benchmarking and research on emerging compliance topics, regulatory developments, and industry best practices to inform program strategy

Qualifications

• 8 or more years of compliance or compliance operations experience in the pharmaceutical industry
• Demonstrated experience building or significantly enhancing a pharmaceutical compliance program, including policy development, training, monitoring, and investigations
• Meaningful experience with HCP engagement programs, including needs assessment review, FMV processes, and professional services agreement compliance
• Experience with compliance risk assessment methodologies and monitoring program design and execution
• Proven ability to serve as a trusted advisor and business partner to commercial, clinical, medical, and operational stakeholders