Overview
A biopharmaceutical oncology company is seeking a Senior Commercial Attorney, Transactions to support the commercial launch of an investigational therapy. This role reports to the Chief Legal Officer and serves as the primary legal liaison for reviewing, negotiating, and drafting commercial, marketing, and market access agreements. The position requires deep knowledge of pharmaceutical industry regulations and commercialization strategies.
Responsibilities
- Lead drafting and negotiation of agreements related to commercial activities including product launches, promotional materials, sales activities, advisory boards, speaker bureaus, patient assistance programs, patient advocacy groups, sponsorships, and charitable contributions
- Draft and negotiate pricing, distribution (3PL, specialty distributors, specialty pharmacy providers, GPOs, PSPs), payer, and reimbursement agreements, including value-based and outcomes-based contracts; define service levels for cold chain management and temperature-sensitive biologics
- Support government program contracting such as Medicare, Medicaid, 340B, and VHCA
- Review, negotiate, and draft Master Services Agreements, Statements of Work/Purchase Orders, and Amendments for Commercial, Marketing, Market Access, and General & Administrative functions
- Develop template agreements supporting commercial activities
- Advise on legal structure of limited distribution networks for specialty drugs, including exclusive provider arrangements with payors or pharmacy benefit managers (PBMs)
- Ensure distribution practices comply with federal and state laws including the Drug Supply Chain Security Act (DSCSA), FDA regulations, and Good Distribution Practice (GDP) standards
- Collaborate with commercial teams on reimbursement, prior authorization support, and co-pay assistance programs for high-cost medications
- Work with Compliance to ensure contracts comply with company policies and applicable laws such as the False Claims Act, Anti-Kickback Statute (AKS), Foreign Corrupt Practices Act (FCPA), GDPR, DOJ Bulk Data Rule, BIOSECURE Act, and transparency laws (e.g., Open Payments/Sunshine Act)
- Establish and participate in company committees supporting Commercial/Marketing and Market Access activities
- Provide legal advice on formulary placement and managed care agreements in U.S. and international markets
- Monitor regulatory changes and enforcement trends in pharmaceutical commercialization and communicate updates to business teams
- Conduct training and educational sessions on legal topics related to pharmaceutical commercialization contracting
- Develop, implement, review, and update policies, procedures, and controls to ensure legal and regulatory compliance in contracting
- Identify, evaluate, and advise on risks associated with commercial transactions and propose innovative solutions to meet business goals while reducing risk
- Maintain clear and prompt communication with internal stakeholders and external parties regarding contract status and issues
- Handle miscellaneous legal tasks or special assignments as needed
Requirements
- Juris Doctorate from an accredited law school and admission to a U.S. state bar in good standing
- Minimum of 8+ years of relevant experience in a major law firm and/or in-house pharmaceutical company legal department
- Extensive independent contract negotiation and drafting experience in the pharmaceutical industry
- Strong understanding of contract law, commercial regulations, and industry standards
- Experience supporting pharmaceutical product launches
- In-depth knowledge of federal and state laws, regulations, and industry codes impacting healthcare compliance and pharmaceutical manufacturers, including drug labeling, advertising, fraud and abuse laws, product liability, and clinical trials
- Precise drafting and strong legal analysis skills
- Ability to communicate complex legal issues effectively to senior management and non-legal stakeholders
- Regulatory expertise in Anti-Kickback statutes, Sunshine Act, and Prescription Drug Marketing Act
- Excellent written and oral communication skills with a professional demeanor
- Strong business acumen and practical problem-solving skills offering positive, creative solutions
- Ability to manage competing priorities in a fast-paced environment and exercise sound commercial and legal judgment
- Self-starter capable of working independently and collaboratively in a team environment
Compensation & Benefits
- Salary range: $217,000 - $271,000 USD
- Actual compensation depends on factors such as skill set, experience, certifications, and work location
- Total compensation package may include bonus, stock, benefits, and other variable compensation
Location
Headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.