Associate Director, Brand Counsel

Definium Therapeutics

1d • $175,000 - $220,000

About The Position

The Associate Director, Brand Counsel is a strategic legal partner to Commercial, Medical Affairs, Regulatory Affairs, Market Access, Corporate Affairs, and Compliance. The attorney will help shape the legal and regulatory framework supporting development and the potential launch and commercialization of Definium assets. The position requires expertise in pharmaceutical advertising and promotion, strong business judgment, and the ability to navigate novel legal and policy considerations.

The role advises brand, marketing, market access, and commercialization teams; supports launch planning and commercialization strategy; and provides practical counsel on brand positioning, customer engagement, and commercialization initiatives. The attorney serves on the Promotional Review Committee (PRC) and Medical Review Committee (MRC), reviews promotional materials, and counsels on applicable FDA, OPDP, FTC, and other federal and state requirements. The role also helps establish promotional review standards, policies, and governance processes as the organization prepares for a potential launch.

The position provides regulatory and healthcare compliance counseling, partners with Compliance and Regulatory Affairs on risk assessments and mitigation, and monitors legal and regulatory developments affecting psychiatric therapies and novel treatment modalities. It offers the opportunity to help shape the legal foundation for the potential launch of a first-in-class psychiatric therapy during Definium's evolution from late-stage development to commercial readiness.

Requirements

• Juris Doctor (J.D.) from an accredited law school.
• Active membership in at least one U.S. state bar.
• Minimum of 5 years of legal experience, including significant pharmaceutical or biotechnology industry experience.
• Demonstrated expertise in FDA-regulated advertising and promotion.
• Experience working within MLR review processes.
• Strong understanding of FDA and OPDP requirements.
• Strong understanding of healthcare fraud and abuse laws.
• Strong understanding of pharmaceutical compliance frameworks.
• Strong understanding of regulatory review and launch preparation.

Nice To Haves

• Experience supporting launch or pre-launch pharmaceutical products.
• Experience in psychiatry, neuroscience, central nervous system (CNS), rare disease, or specialty pharmaceutical products.
• Familiarity with REMS programs and controlled substances.
• Experience supporting Marketing, Market Access, and Medical Affairs.
• Prior experience helping build legal frameworks and governance processes in a growing commercial organization.

Responsibilities

• Act as legal advisor to brand, marketing, market access, and commercialization teams.
• Partner with cross-functional stakeholders to support launch planning and commercialization strategy.
• Advise teams on legal risks and practical solutions related to brand positioning, customer engagement, and commercialization initiatives.
• Support development of a best-in-class commercialization model for innovative psychiatric therapies.
• Serve as a core member of the Promotional Review Committee (PRC) and Medical Review Committee (MRC).
• Review and approve promotional materials directed to healthcare professionals, patients, and caregivers.
• Advise on market-shaping activities, disease education communications, provider engagement strategies, and launch materials.
• Counsel teams on FDA, OPDP, FTC, and federal and state requirements applicable to pharmaceutical promotion.
• Support legal review of sales training materials, websites and digital assets, print media, speaker program materials, advisory board materials, and Medical Affairs materials.
• Help establish promotional review standards, policies, and governance processes for a pre-commercial organization transitioning to launch.
• Advise stakeholders on FDA requirements for promotion and scientific exchange; healthcare fraud and abuse laws; payment transparency and reporting obligations; privacy and data protection requirements, including CAN-SPAM; price transparency reporting obligations; and PhRMA Code compliance.
• Partner with Compliance and Regulatory Affairs on risk assessments and mitigation strategies.
• Monitor emerging legal and regulatory developments affecting psychiatric therapies and novel treatment modalities.

Benefits

• 100% paid health benefits, including medical, dental, and vision coverage for employees and dependents.
• 401(k) program with company match and vesting after the turn of the first month after the start date.
• Flexible time off.
• Generous parental leave.
• Fringe perks.
• May be entitled to additional compensation, including bonus and equity.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree