Associate Director - Compliance

“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.

Associate Director / Director, Compliance

Mineralys Therapeutics is seeking an experienced and highly collaborative compliance professional to play a key role in building, enhancing, and operationalizing a best-in-class compliance program. This individual will serve as a trusted partner to the Compliance Lead and cross-functional stakeholders across the organization, helping to embed a strong culture of integrity, accountability, and ethical decision-making throughout the business.

This role is responsible for designing, implementing, and continuously improving core elements of the compliance program, including policies, training, monitoring, and healthcare professional (HCP) engagement oversight. The ideal candidate brings deep pharmaceutical compliance expertise, strong operational execution capabilities, and the ability to translate complex regulatory requirements into practical, business-friendly solutions.

Reporting to the Compliance Lead, this individual will have meaningful influence on program strategy and will help shape the long-term compliance infrastructure as the company continues to grow.

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.

Core Competencies

• Deep expertise in pharmaceutical compliance requirements, including the Anti-Kickback Statute, False Claims Act, Sunshine Act/Open Payments, PDMA, PhRMA Code, and applicable OIG guidance
• Comprehensive understanding of HCP engagement compliance requirements at both the federal and state levels
• Exceptional written and verbal communication skills, including the ability to present complex compliance matters clearly and concisely
• Demonstrated ability to build collaborative, trusted relationships across functions while maintaining appropriate independence and objectivity
• Strong analytical and critical-thinking skills, with the ability to assess risk, synthesize information, and draw sound, well-reasoned conclusions
• Solutions-focused, approachable mindset that enables compliant business outcomes while upholding the highest ethical standards
• High degree of professional integrity, discretion, and personal accountability

Travel

• This position requires up to 10% travel. Frequently travel is outside the local area and overnight.

This position is 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:  $150,343 - $169,384

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