“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
- Coordinate periodic sample inventories, investigate discrepancies, and implement corrective actions as needed
- Work with sample accountability vendor to maintain accurate sample accountability records and produce reports for internal review and regulatory submissions
- Assist in the development, design, review, and delivery of healthcare compliance related policies, SOPs, and trainings, all consistent with current regulatory guidance and industry best practices (e.g., PhRMA Code, OIG guidance, aggregate spend, third-party funding, sampling, code of conduct)
- Support the compliance function in identifying gaps and proactively developing necessary resources to address compliance risk areas
- Provide practical, solutions-oriented guidance that enables compliant business activities
- Support special projects and initiatives
Qualifications
- Bachelor’s degree required; relevant professional certification (CHC, CCEP) preferred
- 5+ years of progressive experience in healthcare or pharmaceutical compliance, with at least 2 years in a role with direct responsibility for transparency/aggregate spend reporting
- Demonstrated experience managing third-party funding processes (grants, sponsorships, memberships) within a pharmaceutical or life sciences organization
- Hands-on experience with aggregate spend technology platforms (e.g., Veeva Vault, Concur, MedPro, Medispend, Porzio, or comparable systems)
- Familiarity with PDMA sample accountability requirements strongly preferred
- Experience administering compliance training programs and working within an LMS (e.g., Veeva Vault Training, Cornerstone, or similar
Core Competencies
- Deep working knowledge of the Sunshine Act/Open Payments regulations, state transfer of value laws, and applicable OIG guidance
- Strong understanding of the PhRMA Code
- Excellent analytical and problem-solving skills with strong attention to detail and data accuracy
- Ability to translate complex regulatory requirements into practical, operational guidance for business stakeholders
- Strong project management skills with the ability to prioritize and manage multiple workstreams simultaneously
- Outstanding written and verbal communication skills; ability to present compliance information clearly to diverse audiences
- Demonstrated ability to build trusted relationships and influence without direct authority
- High degree of professional integrity, sound judgment, and a collaborative, solutions-focused mindse
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: $175,000 - $190,000
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