Director, Legal

Mineralys Therapeutics

14h•$185,000 - $232,000•Remote

About The Position

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. Mineralys is a fully remote company. The Director, Legal (Commercial and Medical Review) will serve as the lead legal reviewer for promotional and medical materials. This individual will represent Legal in the Medical, Legal, and Regulatory (MLR) review process, will sit on the Promotional Review Committee (PRC) and Medical Review Committee (MRC), and will help design the standards and procedures that allow the company to review materials quickly, through planned launch and into commercialization. This is a hands-on role for an attorney who is comfortable giving clear, practical advice in a fast-moving, remote environment and appreciates autonomy. Reporting to the VP, Commercial Legal, this role is accountable for providing practical legal guidance across advertising and promotion, medical affairs activities, commercial operations, market access initiatives, and product launch planning. This role requires strong interpersonal skills and significant cross-functional interaction across Commercial, Medical Affairs, Regulatory, Legal and Compliance. Experience with patient support programs and related materials would be an asset to the role.

Requirements

JD from an accredited law school and active membership in at least one U.S. state bar
6+ years of legal experience within the 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, including hub services, co-pay assistance, and nurse or educator programs
Experience supporting a product launch, ideally with a pre-commercial or newly commercial biotechnology company
Strong business judgment with a practical, solutions-oriented approach to risk management
Ability to balance legal risk and apply appropriate mitigation strategies
Ability to influence and advise 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

Nice To Haves

Experience with patient support programs and related materials

Responsibilities

Serve as the Legal representative on the PRC and MRC, reviewing HCP-facing, patient-facing, medical, and corporate materials for compliance with the Federal Food, Drug, and Cosmetic Act, FDA advertising and promotion regulations, FTC requirements, and other relevant and applicable industry codes
Provide advice across pre-launch and launch activities, balancing legal risk with business objectives
Review patient materials, including patient education, disease awareness, website and digital content, and patient support program communications, to ensure compliance with relevant regulations
Evaluate claims for substantiation, fair balance, and net impression, including comparative, subgroup, and pharmacokinetic claims, and provide clear direction to reviewers and authors
Advise on pre-approval communications, including scientific exchange, disease awareness, medical education, congress activity, and the boundaries between investor and corporate messaging and promotion of an investigational product
Review non-promotional and medical affairs materials, including responses to unsolicited requests, payor and formulary communications, and digital and social media content
Provide guidance on compliantly navigating the regulatory landscape in business activities such as disease education, HCP engagement, and patient-facing materials
Support corporate legal matters and business development initiatives as needed