Senior Counsel – Compliance

“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

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