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 the Promotional Review Committee and Medical Review Committee.

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

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

• Review patient education, disease awareness, website, digital content, and communications for 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 exchange, 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, and digital/social media content.

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

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

• Contribute to the design of review standards and procedures for upcoming launches and commercialization efforts.

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

⛳️ Requirements

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

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

• Over 6 years of legal experience in the pharmaceutical, biotechnology, or life sciences sector.

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

• Familiarity with product launch planning and commercialization processes.

• Experience in reviewing materials for HCPs and patients.

• Background in advising on patient support programs, including 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.

• Ability to influence and provide advice in a matrixed environment.

• Exceptional communication skills with the ability to translate complex legal and regulatory concepts into actionable business guidance.

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

• Ability to thrive in a fast-paced, resource-constrained setting.

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

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

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Paid time off.

• 401K retirement plan.

• Participation in Mineralys incentive programs contingent on achieving personal and company performance goals.