The Director, Compliance will build and mature Mineralys’ pharmaceutical compliance program. Responsibilities include developing policies and procedures, managing policy lifecycles, administering training, overseeing healthcare professional engagement compliance and fair-market-value reviews, supporting risk-based monitoring and investigations, leading strategic compliance initiatives, and researching regulatory developments. The role requires extensive pharmaceutical compliance experience, knowledge of federal and state HCP requirements, and expertise in applicable healthcare laws and industry guidance.
“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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