Director, Compliance

Mineralys Therapeutics

14h•$220,000 - $235,000•Remote

About The Position

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.

Requirements

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 partner
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

Nice To Haves

relevant professional certification (CHC, CCEP) preferred

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