Lead Counsel, Market Access, Oncology

Role Summary

Lead Counsel, Market Access, Oncology – provide day-to-day legal support to the Patient, Value and Access (PVA) team within the Oncology Business Unit. Advise on pricing, payer and GPO contracting, government price reporting, co-pay programming, and patient services for inline and launch products in the US market. Report to the Head Counsel, Takeda Global Oncology, and work closely with Oncology Business Unit clients to shape strategy and ensure patient access to Takeda’s medicines. Location: Cambridge, MA.

Responsibilities

• Providing strategic legal counsel to management on product pricing and access matters, representing Legal on relevant leadership committees.
• Preparing, reviewing, and negotiating complex government, payer, pharmacy and distributor agreements, including agreements with commercial and Medicare payers, pharmacy benefit managers (PBMs), Oncology GPOs, the Department of Veterans Affairs (VA), Federal Supply Schedule (FSS), Medicaid, the Department of Defense (DOD), specialty pharmacies and distributors.
• Develop and implement business rules and contract playbooks that facilitate speed, efficiency and compliance.
• Serving as counsel for our Government Price Reporting function concerning legal, regulatory, and compliance issues associated with federal government price reporting requirements across the oncology portfolio of medicines.
• Developing deep knowledge of Takeda’s business and keeping abreast of changes in law that affect supported client areas.
• Providing training and guidance for the field representatives and the PVA function.

Qualifications

• Juris Doctor (JD) degree from an accredited law school and bar membership in at least one jurisdiction.
• 10+ years of legal experience with at least 2 years of relevant market access experience in a law firm and/or in-house legal department of a pharmaceutical or device company.
• Proficiency in commercial payer, government payer and trade contracting.
• Developing proficiency in government price reporting requirements, including AMP, Best Price, ASP, and 340B, as well as federal health care program contracting (e.g., Medicaid, VA, etc.).
• Understanding laws impacting the commercial business operations of pharmaceutical and device companies, including the Antikickback Statute, the False Claims Act (FCA), the Food, Drug & Cosmetic Act (FDCA), the Medicaid Statute (Title XIX of the Social Security Act), the Inflation Reduction Act (IRA), and the Affordable Care Act (ACA).
• Excellent analytical skills with demonstrated ability to independently identify practical legal solutions to complex and dynamic challenges, and to work effectively in high-pressure, matrixed environments.
• Superior written and verbal communication skills to convey complex legal & business concepts to business stakeholders.
• High degree of emotional intelligence and ability to work collaboratively and in accordance with Takeda’s values.