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Salary: USD 200,000 - 232,000 / annual
Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing medicines to treat hypertension and related comorbidities including chronic kidney disease, obstructive sleep apnea, and aldosterone-driven diseases. The company's lead candidate, lorundrostat, is a proprietary oral aldosterone synthase inhibitor.
The Director, Legal (Commercial and Medical Review) will serve as the lead legal reviewer for promotional and medical materials, representing Legal in the Medical, Legal, and Regulatory (MLR) review process. This individual will sit on the Promotional Review Committee (PRC) and Medical Review Committee (MRC), helping design standards and procedures for rapid material review through launch and commercialization. Reporting to the VP, Commercial Legal, this is a hands-on role requiring clear, practical advice in a fast-moving, remote environment with significant autonomy.
Key responsibilities include:
- Serve as Legal representative on PRC and MRC, reviewing HCP-facing, patient-facing, medical, and corporate materials for compliance with FDA advertising and promotion regulations, FTC requirements, and industry codes
- Provide advice on pre-launch and launch activities, balancing legal risk with business objectives
- Review patient materials including education, disease awareness, website content, and patient support program communications for regulatory compliance
- Evaluate claims for substantiation, fair balance, and net impression; provide clear direction to reviewers and authors
- Advise on pre-approval communications including scientific exchange, disease awareness, medical education, and boundaries between investor/corporate messaging and investigational product promotion
- Review non-promotional and medical affairs materials, including responses to unsolicited requests, payor communications, and digital/social media content
- Provide guidance on regulatory compliance for disease education, HCP engagement, and patient-facing materials
- Support corporate legal matters and business development initiatives as needed
The role requires up to 10% travel, frequently outside the local area and overnight.
Qualifications:
- JD from accredited law school and active membership in at least one U.S. state bar
- 6+ years of legal experience in pharmaceutical, biotechnology, or life sciences industry
- Strong knowledge of FDA advertising, promotion regulations, and commercial legal requirements
- Knowledge of product launch planning and commercialization activities
- Experience reviewing HCP and patient materials, and advising on patient support programs (hub services, co-pay assistance, nurse/educator programs)
- Experience supporting a product launch, ideally with pre-commercial or newly commercial biotechnology company
- Strong business judgment with practical, solutions-oriented approach to risk management
- Ability to balance legal risk and apply appropriate mitigation strategies
- Ability to influence and advise in matrixed environment
- Excellent communication skills translating complex legal and regulatory concepts into actionable business guidance
- Strong cross-functional collaboration and relationship-building skills
- Demonstrated ability to operate effectively in fast-paced, resource-constrained environment
- High degree of autonomy, accountability, and execution focus
