Director, Product Counsel

Please note that this position can be based in Princeton NJ or San Diego CA. Acadias hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director/Senior Director Product Counsel serves as the primary legal advisor to assigned pharmaceutical brand(s) providing strategic and day-to-day legal support across the full product lifecycle. Provides legal expertise and counsel for all promotional medical clinical and accessrelated activities impacting assigned product(s). Serves as the Legal representative on the Medical Legal and Regulatory (MLR) review committee. Ensures all materials are developed in accordance with Company standards and all applicable laws and regulations. Partners closely with crossfunctional teams to proactively identify assess and mitigate legal and compliance risk while enabling business objectives. Supports Commercial Medical Affairs Market Access and Research & Development (R&D) functions as well as internal and external investigations as needed. May interact with government agencies law firms trade organizations and other external agencies.

Primary Responsibilities

• Acts as lead legal counsel for assigned pharmaceutical brand(s) across pre-launch launch and post-launch phases.
• Provides strategic legal guidance and works closely with leadership on brand strategy messaging and execution to support business objectives while managing legal risk.
• Serves as a core member of brand and cross-functional teams including Commercial Medical Affairs Market Access R&D Compliance and Regulatory Affairs. Legal representative of MLR committee providing timely legal review of all promotional and non-promotional tactics and materials.
• Provides legal advice and counseling on various issues including but not limited to Food & Drug Administration (FDA) labeling clinical operations marketing strategies direct-to-consumer advertising campaigns and programs patient support programs customer interactions healthcare professional (HCP) engagements sales training social media and commercial sponsorships.
• Counsels on federal and state healthcare laws and regulations including Anti-Kickback Statute and False Claims Act.
• Proactively identifies risks opportunities and mitigating actions and collaborates across business functions to implement while enabling innovation.
• Assists with employment law matters and/or investigations as needed.
• Assists with leading engaging coaching and developing teams in the Legal department to foster high performance amongst team.
• Stays informed of new laws regulations and industry trends affecting the company and assists with the development of policies and training as needed.
• Assists with providing oversight to teams and external partners. May serve as a manager.
• Performs other duties as needed or assigned.

Education/Experience/Skills

Juris Doctorate Degree - ABA accredited law school and must be active member of the California or New Jersey State Bars or qualified as Registered In-house Counsel in either State. Eight (8) or more years of relevant legal experience. Experience within the healthcare/pharmaceutical industry is required. Previous product counsel experience preferred. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Deep understanding of the pharmaceutical industry and eventually Acadia product(s) and business model.
• Strong problem-solving skills - demonstrates and exercises creativity and initiative with a solutions-oriented mindset.
• Demonstrated ability to operate as a trusted business partner able to gain trust at and work with all levels of organization.
• High level of integrity with the ability to maintain the protection of proprietary and confidential information.
• Strong written and verbal communications skills - able to effectively collaborate and communicate with client groups senior management and executives within the company.
• Ability to handle multiple projects simultaneously independently.
• Embraces the ideas of others and cultivates a collaborative environment in order to complete assignments effectively.
• Strong knowledge of FDA advertising and promotion regulations healthcare compliance laws and industry standards.
• R&D clinical and/or labeling experience is preferred.
• Experience with AI governance is a plus.

Physical Requirements:

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication both in a standard office environment and while working independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedule or business needs. This position is geographically based.

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