SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Salary: USD 262,022 - 295,584 / annual
Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing medicines to treat hypertension and related conditions including chronic kidney disease, obstructive sleep apnea, and aldosterone-driven diseases. The company's lead candidate, lorundrostat, is a selective aldosterone synthase inhibitor.
The Senior Counsel – Compliance will lead the design, implementation, and oversight of Mineralys' healthcare compliance program. This strategic role is accountable for establishing a scalable compliance framework that supports commercial launch readiness and ongoing operations while ensuring adherence to applicable healthcare laws, regulations, industry standards, and company policies.
Key responsibilities include:
- Designing and implementing a scalable healthcare compliance program aligned with applicable laws and regulations to enable commercialization
- Establishing compliance governance, policies, procedures, standards, and risk management frameworks
- Implementing transparency and aggregate spend reporting processes
- Proactively identifying legal and compliance risks and developing mitigation strategies
- Monitoring evolving healthcare laws, regulations, and industry trends
- Advising on compliance requirements for HCP interactions, speaker programs, advisory boards, consultant engagements, grants, patient support programs, and medical education
- Providing guidance on Anti-Kickback Statute, False Claims Act, Sunshine Act, FDA requirements, PhRMA Code, and state healthcare compliance laws
- Developing and overseeing compliance monitoring, auditing, and testing programs
- Leading investigations of potential compliance concerns and overseeing corrective action plans
- Creating compliance guidance documents, SOPs, and training materials
- Collaborating with Legal, Regulatory, Privacy, Finance, and HR teams on compliance governance
Required qualifications: Bachelor's degree; 12+ years of pharmaceutical, biotechnology, or life sciences compliance experience; significant experience building and leading healthcare compliance programs; expertise in healthcare compliance laws and regulations; experience supporting commercial launch readiness; experience conducting compliance risk assessments, investigations, monitoring, and auditing; experience developing compliance training programs; prior leadership experience in Compliance, Ethics, Legal, or related functions. Advanced degree (JD, PharmD, MBA, MPH) preferred. Experience in pre-commercial or emerging biotech preferred.
Core competencies include strategic and proactive compliance leadership with business acumen, ability to influence senior leaders and drive ethics culture, strong risk assessment and problem-solving skills, excellent communication and training capabilities, ability to balance oversight with business partnership, success in lean high-growth environments, and executive presence.
Position requires up to 10% travel, frequently outside local area with overnight stays. Fully remote role based in the US.
