Mineralys Therapeutics - Senior Counsel – Commercial Legal
Requirements
• JD from an accredited law school and active membership in at least one U.S. state bar • 10+ years of legal experience within the pharmaceutical, biotechnology, or life sciences industry • Strong knowledge of FDA advertising and promotion regulations and commercial legal requirements • Knowledge of product launch planning and commercialization activities • Ability to support Medical Affairs organizations and scientific exchange initiatives • Expertise in drafting, reviewing, and negotiating complex commercial agreements • Experience within a pre-commercial or emerging biotechnology company preferred • Core Competencies • Core Competencies • Strong business judgment with a practical, solutions-oriented approach to risk management • Ability to balance legal risk mitigation with commercial objectives • Ability to influence and advise senior leaders in a matrixed environment • Excellent communication skills with the ability to translate complex legal and regulatory concepts into actionable business guidance • Strong cross-functional collaboration and relationship-building skills • Demonstrated ability to operate effectively in a fast-paced, resource-constrained environment • High degree of autonomy, accountability, and execution focus
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 • Lead legal review of promotional and medical materials through PRC/MRC 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 • Draft, review, and negotiate a wide range of commercial agreements (e.g., vendors, patient support programs, speaker programs, distribution, market access) • Support corporate legal matters and business development initiatives as needed • Manage external counsel effectively
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