Job description
“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 . 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
Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.