Compliance Operations Manager

“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.

Sr. Manager, Compliance Operations

The Senior Manager, Compliance Operations plays a key role within Mineralys’ compliance program and is responsible for operationalizing and sustaining a high-integrity compliance program across the organization. This role partners closely with the commercial, medical, and corporate functions to embed a culture of ethical behavior and regulatory accountability. The ideal candidate brings both technical expertise and a collaborative, approachable mindset to enable sustained business success while upholding the highest standards of compliance. The position will report to Mineralys’ Vice President, Compliance.

Key Responsibilities

• Support the implementation and ongoing optimization of Mineralys’ aggregate spend and transparency reporting system and operational processes to ensure timely and accurate reporting in compliance with federal and state laws (e.g., Sunshine Act/Open Payments, state transfer of value)
  • Develop and maintain data governance protocols, reconciliation processes, and quality controls to ensure data integrity across all reported spend categories
  • Serve as main business owner and liaison to IT and vendor partners
  • Prepare and support submission of aggregate spend reports to relevant government agencies and internal leadership
• Support external funding requests (e.g., corporate sponsorships, corporate memberships, independent medical education, and research grants)
  • Serve as the internal subject matter expert on external funding-related compliance requirements
  • Administer review and approval processes to ensure alignment with applicable regulations, company policies, and fair market value standards
• Support Mineralys’ compliance sample accountability program in accordance with the Prescription Drug Marketing Act (PDMA) and applicable state regulations
  • Liaise with sample accountability vendor, field sales, and commercial operations to support sample request, distribution, storage, and reconciliation procedures