“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.
Senior Counsel - Compliance
The Senior Director, Compliance will lead the design, implementation, and oversight of Mineralys' healthcare compliance program. This individual is accountable for establishing a scalable compliance framework that supports commercial launch readiness and ongoing business operations while ensuring adherence to applicable healthcare laws, regulations, industry standards, and company policies.
Operating in a fast-paced, pre-commercial biotech environment, this role requires a strategic compliance leader capable of partnering across Commercial, Medical Affairs, Regulatory, Finance, Human Resources, and Executive Leadership.
Key Responsibilities
- Lead design and implementation of a scalable healthcare compliance program aligned with applicable laws, regulations, and industry guidance to enable commercialization success
- Establish compliance governance, policies, procedures, standards, and risk management frameworks
- Implement transparency and aggregate spend reporting processes
- Proactively identify legal and compliance risks and develop practical mitigation strategies
- Monitor evolving healthcare laws, regulations, and industry trends
- Advise on compliance requirements related to HCP interactions, speaker programs, advisory boards, consultant engagements, grants, patient support programs, and medical education activities
- Provide guidance regarding the Anti-Kickback Statute, False Claims Act, Sunshine Act, FDA requirements, PhRMA Code, and applicable state healthcare compliance laws
- Develop and oversee compliance monitoring, auditing, and testing programs
- Lead investigations of potential compliance concerns and oversee corrective and preventive action plans
- Create and maintain compliance guidance documents, SOPs, and training materials
- Oversee transparency reporting and related compliance obligations
- Monitor regulatory developments, enforcement trends, and industry guidance and assess impact on Company practices
- Collaborate with Legal, Regulatory, Privacy, Finance, and Human Resources teams on compliance governance initiatives
Qualifications
- Bachelor’s degree required; advanced degree preferred
- JD, PharmD, MBA, MPH, or other relevant advanced degree preferred
- 12+ years of pharmaceutical, biotechnology, or life sciences compliance experience
- Significant experience building, implementing, or leading healthcare compliance programs
- Expertise in healthcare compliance laws and regulations, including the Anti-Kickback Statute, False Claims Act, Sunshine Act, FDA requirements, and PhRMA Code
- Experience supporting commercial launch readiness and commercial-stage operations
- Experience conducting compliance risk assessments, investigations, monitoring, and auditing activities
- Experience developing and delivering compliance training programs
- Prior leadership experience within Compliance, Ethics, Legal, or related functions
- Experience within a pre-commercial or emerging biotechnology company preferred
Core Competencies
- Strategic and proactive compliance leadership with strong business acumen
- Ability to influence senior leaders and drive a culture of ethics, integrity, and accountability
- Strong risk assessment, problem-solving, and decision-making skills
- Excellent communication and training capabilities
- Ability to balance compliance oversight with business partnership
- Demonstrated success operating in a lean, high-growth environment
- Executive presence and ability to interact effectively with senior leadership and Board members
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: $262,022 - $295,584
#LI-Remote
Skills Required
- J.D. from an accredited law school
- Active bar membership in at least one U.S. jurisdiction
- 8-12+ years of legal experience in biotech/pharma
- In-house legal experience in biotech/pharma
- Proven experience supporting commercial build and product launch
- Deep knowledge of healthcare and compliance laws and regulations (FDA, OIG, PhRMA Code, Anti-Kickback, False Claims Act, Sunshine Act, etc.)
- Strong experience with MLR/PRC review, promotional regulations, and compliance program development
- Experience drafting and negotiating complex commercial agreements
- Ability to operate in a fast-paced, evolving environment with high accountability
- Strong cross-functional leadership, collaboration, and judgment
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What We Do
Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing lorundrostat, a proprietary oral aldosterone synthase inhibitor, to treat uncontrolled and resistant hypertension and related cardiorenal disorders (including CKD and OSA). The company focuses on targeted therapies for diseases driven by dysregulated aldosterone and is advancing late-stage clinical programs and regulatory filings to bring this treatment to patients.
