Director, Legal (Commercial and Medical Review)

The role

The Director, Legal (Commercial and Medical Review) will serve as the lead legal reviewer for promotional and medical materials. This person will provide legal guidance across advertising, promotion, medical affairs, commercial operations, market access, and product launch planning.

What you will do

• Serve as the Legal representative on the PRC and MRC
• Review HCP-facing, patient-facing, medical, and corporate materials for compliance
• Provide advice across pre-launch and launch activities
• Review patient materials including education, disease awareness, website, digital content, and patient support program communications
• Evaluate claims for substantiation, fair balance, and net impression
• Advise on pre-approval communications including scientific exchange and medical education
• Review non-promotional and medical affairs materials
• Provide guidance on navigating the regulatory landscape in business activities
• Support corporate legal matters and business development initiatives

Required qualifications

• JD from an accredited law school
• 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
• Experience advising on patient support programs, including hub services, co-pay assistance, and nurse or educator programs

Nice to have

• Experience with patient support programs and related materials
• Experience supporting a product launch, ideally with a pre-commercial or newly commercial biotechnology company

Benefits

• Medical
• Dental
• Vision
• Time off
• 401K
• Participating in Mineralys incentive plans contingent on achievement of personal and company performance

About the company

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. It is headquartered in Radnor, Pennsylvania.