Overview
This role serves as the Lead Affiliate Counsel, acting as the primary legal contact for one or more affiliates within a biopharmaceutical organization focused on rare diseases. The position requires managing the full spectrum of legal matters—commercial, compliance, employment, contracts, and operational issues—while coordinating with internal legal specialists and cross-functional teams. The Lead Affiliate Counsel ensures affiliates receive timely, high-quality legal support to operate confidently and compliantly.
Responsibilities
- Serve as the single point of legal contact for affiliate leadership on all legal matters.
- Manage and coordinate legal support across the internal legal team, determining when to handle issues directly or involve specialists.
- Provide strategic legal counsel across commercial strategy, healthcare provider and organization engagement, promotional materials, patient programs, payer and market access, contracts, and operational matters.
- Collaborate with Commercial, Medical Affairs, Finance, HR, Compliance, and Regulatory teams to resolve issues efficiently.
- Participate in the Material Review Committee (MLR) to ensure promotional and scientific materials are accurate, balanced, and compliant.
- Partner with Compliance and Regulatory teams to develop and improve MLR processes suitable for a growing multi-product commercial organization.
- Proactively identify and flag legal and reputational risks, working with appropriate legal specialists to address them.
- Collaborate with the Head of Compliance on healthcare fraud and abuse matters, including Anti-Kickback Statute (AKS) and False Claims Act (FCA) considerations.
- Maintain responsiveness, decisiveness, and clarity in a fast-paced commercial environment, balancing speed and caution as needed.
Requirements
- Juris Doctor (J.D.) degree from a nationally recognized law school.
- Admission to practice law in the United States.
- Minimum of 10 years of legal experience in pharmaceutical or biotechnology sectors.
- Significant exposure to commercial operations, product launches, and cross-functional legal support.
- Broad legal knowledge including commercial healthcare law, AKS, FCA, FDA promotional regulations, contracts, employment, intellectual property, and operational matters.
- Experience supporting at least one commercial product launch, understanding the pace and cross-functional dynamics involved.
- Strong communication skills with the ability to advise diverse audiences, including field teams, affiliate leadership, and senior legal counsel.
- Proven ability to build trusted relationships and serve as a reliable legal advisor.
- Ability to manage multiple priorities in a multi-product, multi-affiliate environment with resilience and intellectual curiosity.
- Bay Area (Palo Alto or San Francisco) location strongly preferred; remote candidates must commit to regular Bay Area travel. Relocation support is available for the right candidate.
Preferred Qualifications
- Experience working in both law firm and in-house legal environments.
- Demonstrated ability to lead legal frameworks that scale with organizational growth.
- Familiarity with healthcare fraud and abuse laws and compliance programs.
Compensation & Benefits
- Salary range for California-based candidates: $305,000 to $350,000 USD annually.
- Market-competitive total rewards package including base pay, annual performance bonus, and company equity.
- 401(k) plan with employer match.
- Employee Stock Purchase Program (ESPP).
- Pre-tax commuter benefits for transit and parking.
- Referral bonuses for hired candidates.
- Subsidized lunch and parking on in-office days.
- 100% employer-paid medical, dental, and vision premiums for employees and dependents.
- Health Savings Account (HSA) with employer contributions and Flexible Spending Accounts (FSA).
- Fertility and family-forming benefits.
- Expanded mental health support including therapy and coaching.
- Hybrid work model with flexible scheduling.
- Flexible paid time off and company-paid holidays.
- Comprehensive paid medical and parental leave.
- Opportunities for skill development, career pathing, and internal mobility through continuous education and professional development programs.
Location
- Bay Area, California (Palo Alto or San Francisco) preferred.
- Remote candidates considered with commitment to regular Bay Area travel.
- Relocation support available for qualified candidates.