Lead Counsel, Commercial Brands, Oncology Business Unit

Role Summary

Lead Counsel, Commercial Brands supporting the US Commercial and Medical Teams within the Oncology Business Unit. Provides strategic legal guidance on FDA laws and regulations, anti-kickback/bribery statutes, false claims acts, transparency laws, HIPAA, and other regulatory frameworks governing US and international pharmaceutical commercialization. Reports to the Head Counsel, Takeda Global Oncology, and collaborates with Oncology Commercial and Medical Affairs clients. Location: Cambridge, MA.

Responsibilities

• Provide impactful, succinct, and timely legal advice to commercial and medical leaders and staff within the Oncology Business Unit to support informed decision making with risk-based guidance.
• Participate in US and global integrated brand teams and compliance committees to guide the development of commercial and medical strategies and help manage legal risk.
• Advise on FDA laws and regulations, anti-kickback/bribery statutes, false claims acts, transparency laws (federal/state), HIPAA, state privacy laws, and other laws governing commercialization in US and internationally.
• Support leadership teams including the above-brand review committee and US Compliance Committee.
• Collaborate across Compliance, Regulatory, and Medical Affairs to support policy, training, and monitoring frameworks that drive agility and integrity.
• Manage engagements with outside firms, develop internal budgets, and allocate resources in line with business objectives and external context.
• Collaborate with strategic partners to implement development and commercialization alliances.
• Provide strategic advice on regulatory, AKS, and privacy risks in access and patient support services.
• Review financial and other interactions with healthcare professionals, patients, payers, advocacy groups, distributors, and others to ensure compliance.
• Prepare, review, and negotiate complex commercial vendor agreements.
• Apply strategic and tactical legal support to ensure brand strategies are executed with appropriate mitigation plans.
• Develop deep knowledge of Takeda’s business and stay current on laws affecting supported client areas.
• Collaborate with the legal team and other functions, including regulatory and compliance; pursue process improvements and digital tools to increase efficiency.

Qualifications

• Juris Doctor (JD) from an accredited law school and bar membership in at least one jurisdiction.
• 8–10 years of relevant experience in a law firm and/or in-house legal department of a pharmaceutical or device company.
• Some experience leading teams and developing/implementing budgets (preferred).
• Broad experience advising commercial and medical functions (marketing, sales, access, medical); experience with pharmaceutical and device regulation preferred, including injectable devices and companion diagnostics.
• Solid expertise in laws impacting commercial operations of pharmaceutical and device companies, including Anti-kickback Statute, FCA, FDCA, Medicaid Statute, IRA, and ACA.
• Excellent analytical skills and ability to develop practical legal solutions in high-pressure, matrixed environments.
• Strong written and verbal communication skills to convey complex legal and business concepts.
• High emotional intelligence and ability to work collaboratively in alignment with Takeda’s values.