Associate General Counsel (Commercial)

Overview

A late-stage biotechnology organization is seeking an Associate General Counsel to lead the commercial legal function and support the first U.S. product launch. This role reports to the SVP, Legal, and serves as a trusted strategic partner providing practical, timely, and business-savvy legal advice to Commercial (Sales, Marketing, Market Access), Medical Affairs, and Patient Support teams. The position requires expertise in U.S. healthcare laws, FDA promotional regulations, and industry codes to ensure legal and compliant pre-launch, launch, and ongoing commercial and medical activities.

Responsibilities

Commercial & Medical Affairs Legal Support

• Act as key legal partner and subject matter expert to commercial and medical teams
• Provide legal advice on pre-launch activities and launch strategy, including medical science liaison (MSL) activities, disease awareness, sales, marketing campaigns, marketing analytics, patient advocacy programs, advisory boards, and incentive compensation
• Counsel market access on pricing, reimbursement, distribution, contracting structures, payer engagement issues (including PIE and FDAMA 114)
• Draft and lead development of market access and patient support agreements
• Advise patient support teams on legal issues related to patient support and hub services
• Serve as legal representative on Promotional Review Committee, Medical Legal Regulatory Review Committee, Publications Review Committee, ISR reviews, grants and sponsorships committees, and similar bodies
• Provide training to applicable personnel
• Oversee outside counsel and conduct/respond to diligence for financings, business development, and review external corporate content such as press releases

Compliance Program Support

• Partner with Compliance to advise commercial, medical, and advocacy teams on compliance obligations
• Collaborate to evolve the U.S. compliance program consistent with company size, scope, and values
• Coordinate training activities related to legal and compliance responsibilities, ethics, policies, and procedures
• Support development and enhancement of compliance policies and SOPs related to Anti-Kickback Statute (AKS), False Claims Act (FCA), and industry codes

Requirements

• Juris Doctor (JD) degree required
• Minimum 12 years of relevant legal experience in the biopharmaceutical industry; biotechnology experience preferred
• Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, and industry codes
• Experience reviewing promotional and medical materials
• Ability to interpret and apply healthcare laws to complex business plans
• Experience supporting product launch planning and cross-functional review committees; experience with first U.S. launch preferred
• Strong business partnering skills with ability to balance risk and business goals
• Excellent communication skills
• Ability to manage multiple priorities in a fast-paced, evolving environment; comfortable working in a demanding start-up culture

Compensation & Benefits

• Annual salary range based on experience, education, location, internal equity, and other job-related factors
• For remote positions, salary may vary based on local market
• Eligibility for pre-IPO equity and annual bonus
• Competitive medical, dental, and vision benefits
• Paid time off (PTO)
• 401(k) plan
• Life and accidental death and disability coverage
• Parental leave benefits
• Additional perks include subsidized daily lunches and snacks at on-site locations

Location and Travel

• Remote-based candidates supported
• Travel up to 15% expected

Additional Information

This organization is an equal opportunity employer committed to diversity and inclusion. Staffing agencies without a written agreement and specific engagement for this position should not submit resumes. Employment activities and candidate submissions are managed exclusively through the internal HR/Talent team.