Takeda · 2 days ago
Lead Counsel, Commercial Brands, Oncology Business Unit
Cambridge, MA
Full-time
Hybrid
Lead/Staff
$229K/yr - $360K/yr
8+ years expTakeda is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. As Lead Counsel, Commercial Brands, you will provide strategic legal guidance to the US Commercial and Medical Teams within the Oncology Business Unit, advising on various laws and regulations governing the commercialization of pharmaceutical products.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Providing impactful, succinct, and timely legal advice to commercial and medical leaders and staff members within the Oncology Business Unit (OBU) in a manner that supports informed decision making with risk-based guidance
Participating in US and global integrated brand teams as well as other above brand leadership teams and the compliance committee, guiding the development of commercial and medical strategies and helping the teams manage and mitigate legal risk
Advising on FDA laws and regulations, anti-kickback and bribery statutes, false claims acts, transparency laws (federal and state on TOV, and state pricing transparency), the Health Insurance Portability and Accountability Act (HIPAA), state privacy laws and other relevant laws and regulations governing the commercialization of pharmaceutical products in both the US and international jurisdictions
Supporting relevant leadership teams, including the above-brand review committee and the US Compliance Committee
Working collaboratively across functions, including Compliance, Regulatory and Medical Affairs, to support a policy, training and monitoring framework that drives agility and operational integrity
Managing engagements with outside firms, developing internal budgets and considering prioritization and resource allocation in a manner that reflects the objectives of the business and the evolving context of the external environment
Working collaboratively with strategic partners, driving the successful implementation of development and commercialization alliances
Providing strategic advice regarding the assessment and mitigation of regulatory, AKS and privacy risks that can arise in the development and implementation of access and patient support services
Reviewing financial and other interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations
Preparing, reviewing, and negotiating complex commercial vendor agreements
Working effectively at the strategic and tactical level of the business operation to ensure that brand strategies and mitigation plans are pulled through into the execution
Developing deep knowledge of Takeda’s business and keeping abreast of changes in law that affect supported client areas
Working collaboratively and effectively with colleagues on the legal team as well as colleagues across other functions, including regulatory and compliance
Proactively improving ways of working, adopting innovative digital solutions that improve efficiency and allow smarter resource allocation
Qualification
Required
Juris Doctor (JD) degree from an accredited law school and bar membership in at least one jurisdiction
At least 8 to 10 years of relevant experience in a law firm and/or in-house legal department of a pharmaceutical or device company
Solid expertise in the 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
Preferred
Some experience leading teams and developing/implementing budgets preferred
Broad experience advising commercial and medical functions, including marketing, sales, access and medical. Experience with both pharmaceutical and device regulation preferred, with particular focus on injectable devices and companion diagnostics
Benefits
U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase