Associate General Counsel – Commercial

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

📋 Description

• Direct the commercial legal function, primarily focusing on supporting the anticipated first U.S. product launch.

• Act as a trusted strategic partner by providing practical, timely, and business-oriented legal counsel to the Commercial (Sales, Marketing, Market Access), Medical Affairs, and Patient Support divisions.

• Serve as a subject matter expert (SME) on U.S. healthcare legislation, FDA promotional regulations, and industry codes to facilitate legal and compliant pre-launch, launch, and ongoing commercial and medical initiatives.

• Collaborate with Compliance to ensure the Company’s U.S. compliance program is risk-based, purpose-driven, and in alignment with corporate values.

• Provide support to cross-functional teams through advisory roles, training, and policy formulation.

⛳️ Requirements

• Juris Doctor (JD) required, with a minimum of 12 years of relevant legal experience in the biopharmaceutical sector (biotech experience preferred).

• Extensive understanding of FDA promotional regulations, the Anti-Kickback Statute, the False Claims Act, OIG Guidance, and industry codes, along with the ability to stay informed on evolving trends and enforcement.

• Proven experience in reviewing promotional and medical materials.

• Capacity to interpret and apply healthcare laws to intricate business strategies.

• Experience in supporting product launch planning and cross-functional review committees (preferably with first U.S. launch experience).

• Strong business partnership abilities with a talent for balancing risk with business objectives.

• Exceptional communication skills.

• Ability to juggle multiple priorities in a fast-paced setting; comfortable operating in a demanding start-up environment with evolving processes; adaptable and flexible in response to new business requirements.

🏝️ Benefits

• Competitive medical, dental, and vision benefits.

• Paid Time Off (PTO).

• 401(k) plan.

• Life and accidental death and disability insurance.

• Parental leave benefits.

• Subsidized daily lunches and snacks at our on-site locations.