Senior Council, Commercial and Compliance
Mineralys Therapeutics, Inc.
8 hours ago
Remote
United States
Corporate Functions
Senior Counsel, Commercial & Compliance
Key Responsibilities
- 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 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 (e.g., speaker programs, advisory boards, sponsorships, grants, medical information requests, scientific exchange)
- Provide guidance on compliantly navigating regulatory landscape (e.g., disease education, HCP engagement, advisory boards, patient-facing materials)
- Lead design and implementation of a scalable healthcare compliance program aligned with applicable laws, regulations, and industry guidance
- Develop policies, procedures, training, and monitoring 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
- Provide business-oriented guidance to senior leadership
- 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/Additional Profile
- Strategic, pragmatic, solutions-oriented
- Strong cross-functional partner and influencer
- High integrity and sound judgment; balances urgency and quality
- Hands-on builder who can scale processes
Benefits/Travel
- Up to 10% travel (often outside local area and overnight)
- Eligible for standard company benefits (medical, dental, vision, time off, 401K) and participation in incentive plans contingent on performance
- US salary range: $250,000–$285,000
Key Responsibilities
- 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 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 (e.g., speaker programs, advisory boards, sponsorships, grants, medical information requests, scientific exchange)
- Provide guidance on compliantly navigating regulatory landscape (e.g., disease education, HCP engagement, advisory boards, patient-facing materials)
- Lead design and implementation of a scalable healthcare compliance program aligned with applicable laws, regulations, and industry guidance
- Develop policies, procedures, training, and monitoring 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
- Provide business-oriented guidance to senior leadership
- 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/Additional Profile
- Strategic, pragmatic, solutions-oriented
- Strong cross-functional partner and influencer
- High integrity and sound judgment; balances urgency and quality
- Hands-on builder who can scale processes
Benefits/Travel
- Up to 10% travel (often outside local area and overnight)
- Eligible for standard company benefits (medical, dental, vision, time off, 401K) and participation in incentive plans contingent on performance
- US salary range: $250,000–$285,000