Director, Legal – Commercial and Medical Review

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the Legal representative on both the Promotional Review Committee and the Medical Review Committee.

• Assess HCP-facing, patient-facing, medical, and corporate materials to ensure compliance with FDA, FTC, and relevant industry standards.

• Provide legal counsel throughout pre-launch and launch phases, balancing legal risks with business goals.

• Review communications related to patient education, disease awareness, websites, digital content, and patient support programs.

• Analyze claims for substantiation, fair balance, and overall impression, including comparative, subgroup, and pharmacokinetic claims.

• Offer guidance on pre-approval communications, scientific exchanges, disease awareness, medical education, congress activities, and investor/corporate messaging boundaries.

• Evaluate non-promotional and medical affairs materials, responses to unsolicited requests, payor and formulary communications, as well as digital/social media content.

• Direct compliant business activities related to disease education, HCP engagement, and patient-facing materials.

• Assist with corporate legal matters and business development initiatives as required.

• Aid in the design of review standards and procedures for upcoming launches and commercialization efforts.

• Report to the VP of Commercial Legal and collaborate cross-functionally with Commercial, Medical Affairs, Regulatory, Legal, and Compliance teams.

⛳️ Requirements

• Juris Doctor (JD) degree from an accredited law school.

• Active membership in at least one U.S. state bar.

• A minimum of 6 years of legal experience in the pharmaceutical, biotechnology, or life sciences sectors.

• In-depth understanding of FDA advertising, promotion regulations, and commercial legal requirements.

• Familiarity with product launch planning and commercialization processes.

• Experience in reviewing materials directed at HCPs and patients.

• Proven track record in advising on patient support programs, such as hub services, co-pay assistance, and nurse or educator initiatives.

• Experience in supporting product launches, preferably with a pre-commercial or newly commercial biotechnology firm.

• Strong business acumen and a practical, solutions-oriented approach to risk management.

• Capability to balance legal risks and implement mitigation strategies.

• Skill in influencing and advising within a matrixed environment.

• Excellent communication abilities, with a talent for translating complex legal and regulatory concepts into actionable business guidance.

• Strong skills in cross-functional collaboration and relationship building.

• Ability to function effectively in a fast-paced, resource-limited environment.

• High level of autonomy, accountability, and focus on execution.

• Willingness to travel up to 10%, often outside the local area and requiring overnight stays.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Generous time off.

• 401K plan.

• Eligibility to participate in Mineralys incentive programs, contingent on meeting personal and company performance benchmarks.