Lead Counsel, Commercial Brands, Oncology Business Unit

Takeda•Cambridge, MA

23d•Remote

About The Position

As Lead Counsel, Commercial Brands, you will be responsible for providing strategic legal guidance to the US Commercial and Medical Teams within the Oncology Business Unit. You will participate in US and global integrated brand teams, advising on FDA laws and regulations, anti-kickback and bribery statutes, false claims acts, transparency laws and other relevant laws and regulations governing the commercialization of pharmaceutical products in both the US and international jurisdictions. Your work will involve inline commercial brands, as well as pipeline assets. You will report to the Head Counsel, Takeda Global Oncology, and you will work very closely with your Oncology Commercial and Medical Affairs clients. As a member of the extended Takeda Oncology team, your work will contribute to our bold, inspiring vision to cure cancer. In this role, you will help shape the strategic and tactical elements of this important function and you will contribute to a culture that reflects a strong commitment to patients.

Requirements

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.
Broad experience advising commercial and medical functions, including marketing, sales, access and medical.
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.

Nice To Haves

Some experience leading teams and developing/implementing budgets preferred
Experience with both pharmaceutical and device regulation preferred, with particular focus on injectable devices and companion diagnostics.

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.

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.

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