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.

Director, Compliance

The Director, Compliance will play a central role in building, evolving, and operationalizing Mineralys’ compliance program. The ideal candidate has broad compliance operations experience and a genuine commitment to fostering a culture of integrity. This position will report to Mineralys’ Vice President, Compliance.

Key Responsibilities

Serve as a key member of the Compliance function to build, refine, and continuously mature a best-in-class compliance program aligned with OIG guidance, industry standards, and Mineralys’ strategic priorities

Lead the development, drafting, implementation, and periodic refresh of healthcare 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

Partner with business to manage Mineralys’ healthcare professional (HCP) engagement program

Serve as a subject matter expert to the business and evaluate proposed HCP engagements for legitimate business need, appropriate fair market value (FMV) compensation, and consistency with legal and regulatory requirements

Support the implementation of 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 as may be required

Lead strategic compliance projects and initiatives to strengthen the effectiveness, efficiency and maturity of the compliance program

Perform benchmarking and research on emerging compliance topics, regulatory developments, and industry best practices to inform program strateg

Qualifications

Bachelor’s degree required; relevant professional certification (CHC, CCEP) preferred

12+ 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 track record as a trusted business partne

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: $220,000 - $235,000

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