Associate General Counsel (Commercial)
RemoteMenlo Park, California, United States
Job Summary
Lead the commercial legal function and serve as the primary strategic partner to Commercial, Medical Affairs, and Patient Support teams to enable the company's first U.S. product launch. Provide practical legal advice on pre-launch activities, launch strategy, and ongoing commercial and medical activities, acting as the subject matter expert on U.S. healthcare laws, FDA regulations, and industry codes. Counsel market access on pricing, reimbursement, and contracting structures while drafting agreements and reviewing content for promotional, medical, and publications review committees. Oversee outside counsel, conduct diligence for financings, and coordinate training and policy development to ensure the U.S. compliance program remains risk-based and aligned with corporate values. This role reports to the SVP, Legal, with up to 15% travel expectations and eligibility for pre-IPO equity and annual bonuses.
Required Qualifications
- JD required
- 12+ years of relevant legal experience in the biopharmaceutical industry
- biotech preferred
- Deep knowledge of FDA promotional regulations
- Anti-Kickback Statute
- False Claims Act
- OIG Guidance
- ability to stay current on evolving trends and enforcement
- Experience reviewing promotional and medical materials
- Ability to interpret and apply healthcare laws to complex business plans
- Experience supporting product launch planning
- experience building for first US launch preferred
- Strong business partnering skills
- ability to balance risk and business goals
- Excellent communication skills
- Ability to manage multiple priorities in a fast-paced environment
- comfortable working in a demanding start-up culture
- evolving processes
- flexible and able to adapt to new situations as the business demands
Desired Qualifications
- remote-based candidates
- Travel expectations: up to 15%
- experience building for first US launch preferred
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