Director, Commercial & Medical Legal Counsel

Overview

A clinical-stage biopharmaceutical organization focused on developing novel treatments for brain health disorders is seeking a Commercial & Medical Counsel. This role involves providing strategic legal guidance to commercial and medical affairs teams to ensure compliant commercialization of innovative product candidates targeting neurotransmitter pathways.

Responsibilities

• Provide day-to-day legal counsel to Sales, Marketing, Market Access, Medical Affairs, HEOR, and Patient Advocacy teams on regulatory matters including labeling, advertising and promotion, drug safety, market research, scientific exchange, and interactions with healthcare professionals and patients.
• Serve as a core member of promotional and medical MLR Review Committees, advising on advertising, promotion, and scientific exchange.
• Advise on interactions with healthcare professionals, payers, patients, and patient advocacy organizations, identifying and mitigating compliance risks.
• Review and draft contracts to ensure compliance with relevant regulatory standards.
• Ensure adherence to all applicable laws, regulations, policies, procedures, and controls within supported business areas.
• Develop and deliver training on legal and compliance issues to business partners.
• Communicate legal advice clearly and effectively to business stakeholders.

Requirements

• Juris Doctorate and admission to practice law in at least one U.S. state.
• Minimum of 5 years of legal experience, including advising pharmaceutical or life sciences clients; in-house pharmaceutical industry experience preferred.
• Strong understanding of FDA promotional guidance, the Anti-Kickback Statute, False Claims Act, PhRMA Code, and relevant HHS-OIG guidance.
• Excellent interpersonal skills with the ability to present complex information clearly and influence management at all levels.
• Experience with state price reporting, transparency reporting, or privacy matters is preferred.
• Ability to provide clear, actionable guidance in a fast-paced environment while managing multiple priorities.
• High degree of professional ethics and integrity.

Compensation & Benefits

• Starting base salary range: $217,877.00 - $260,733.00, determined by skill set, experience, and geographic location.
• Eligibility for additional compensation including bonuses and equity.
• Comprehensive benefits package including:
  • 100% paid Medical, Dental, and Vision coverage for employees and dependents.
  • 401(k) program with company match and vesting starting the month after hire.
  • Flexible time off.
  • Generous parental leave and additional fringe benefits.

Location

Details regarding the geographic location and remote work options are not specified.