Senior Counsel, Commercial and Compliance at Mineralys Therapeutics

, , United States -

Full Time

Start Date

Immediate

Expiry Date

28 Aug, 26

Salary

285000.0

Posted On

30 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Commercial Legal Leadership, Healthcare Compliance, MLR/PRC Review, Contract Negotiation, FDA Regulations, Anti-Kickback Statute, False Claims Act, Sunshine Act, PhRMA Code, Product Launch Strategy, Risk Management, Strategic Counseling

Industry

Biotechnology Research

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 https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. Senior Counsel, Commercial & Compliance Mineralys is seeking an energetic, versatile, and highly driven attorney to serve as Senior Counsel, Commercial and Compliance. This individual will serve as a strategic legal partner to the Commercial and Medical Affairs teams and will report directly to the Chief Legal Officer. Prior experience assisting with commercial launch is essential. Key Responsibilities Commercial Legal Leadership Serve as the primary legal advisor to the Commercial and Medical Affairs teams Provide strategic counsel across pre-launch and launch activities, balancing legal risk with business objectives Support commercialization readiness, including promotional strategy, market access, patient services, and distribution models Draft, review, and negotiate a wide range of commercial agreements (e.g., vendors, patient support programs, speaker programs, distribution, market access) Lead legal review of promotional and medical materials through MLR/PRC processes Advise on interactions with HCPs, patients, payors, specialty pharmacies, and government entities Support commercial and medical affairs activities, including speaker programs, advisory boards, sponsorships, grants, medical information requests, and scientific exchange Provide guidance on compliantly navigating regulatory landscape in business activities such as disease education, HCP engagement, advisory boards, and patient-facing materials Compliance Program Build & Oversight Lead design and implementation of a scalable healthcare compliance program aligned with applicable laws, regulations, and industry guidance to enable commercialization success Develop policies, procedures, training, and monitoring frameworks Implement transparency and aggregate spend reporting processes Risk Management & Strategy Proactively identify legal and compliance risks and develop practical mitigation strategies Monitor evolving healthcare laws, regulations, and industry trends Provide clear, business-oriented guidance to senior leadership Broader Legal Support Support corporate legal matters and business development initiatives as needed Manage external counsel effectively Contribute to building a high-impact, collaborative legal team Qualifications 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 preferred) 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 Leadership Profile Strategic, pragmatic, and solutions-oriented Strong cross-functional partner, collaborator, and influencer at all levels of the organization High integrity with sound judgment Able to balance urgency and quality Hands-on builder who can scale processes as the organization grows 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: $250,000 - $285,000 #LI-Remote

Responsibilities

Serve as the primary legal advisor to Commercial and Medical Affairs teams, focusing on pre-launch and launch activities. Lead the design and implementation of a scalable healthcare compliance program and manage commercial agreements.