DescriptionThe Executive Director, Value and Access and Legal Policy, leads a team of attorneys and subject matter experts who provide strategic legal advice on market access, pricing and related policy matters for the Human Pharma business. As lead attorney and a member of the Value and Access Leadership Team, this role develops legal strategies and risk mitigation approaches for areas including payor sales and marketing, contracting, pricing, HEOR, trade, and direct-to-patient and other drug distribution models. The role also leads legal policy matters in the Value and Access area in close collaboration with senior leadership, Value and Access, and Corporate Affairs.
This highly visible role works closely with colleagues across the U.S. and Global Legal functions, senior leaders in the U.S. and Germany, and external industry and government stakeholders. This seasoned leader navigates complex issues, demonstrates sound problem-solving and project management skills, and communicates effectively with varied audiences.
This position is located in Ridgefield, CT.
Compensation DataThis position offers a base salary typically between $250,000 and $394,000. This position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
Duties & Responsibilities- Advises business partners, including senior leadership, on initiatives in a way that advances the company's strategy while addressing legal risks and protecting the company's integrity and reputation.
- Leads a team that provides legal advice and counsel on matters such as: (1) statutory and regulatory obligations under Medicaid, Medicare, 340B program, Veterans Health Care Act; (2) the Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program (DPNP) and drug pricing approaches including, but not limited to, most-favored-nation drug pricing models; (3) market access and reimbursement issues; (4) government pricing, including price reporting compliance policies and reasonable assumptions documents; (5) Centers for Medicare and Medicaid final rules and correspondence including letters and public comments on proposed rules and guidance; (6) proposed and enacted United States federal and state legislation impacting pharmaceutical companies relating to market access, pricing, reimbursement as well as state drug price reporting and transparency laws and compliance; (7) services and contracting relating to specialty distributors and specialty pharmacies; and (8) innovative drug distribution models, including direct-to-patient sales.
- Works closely with Corporate Affairs and Value and Access to monitor changes in healthcare legislation, regulations, and enforcement trends. Engages with industry and external groups to shape the company's market access policy positions. Anticipates and communicates regulatory and policy developments and adjusts legal strategies accordingly.
- Regularly engages with and presents to senior leaders on external policy developments and drug pricing topics, translating complex legal, regulatory, and market access issues into clear, actionable guidance to inform business strategy and risk mitigation.
- Ensures compliance with applicable laws and company policies, including Anti-Kickback Statute, the Stark Law, the False Claims Act, the Federal Trade Commission Act, and other US healthcare compliance laws and regulations.
- Leads and develops a collaborative team of attorneys that delivers practical legal guidance and effective risk mitigation strategies.
- Collaborates with Human Pharma Legal and Compliance colleagues, both in the U.S. and globally.
- Actively participates as a member of the Value and Access Leadership Team and on the Pricing and Terms Committee.
Requirements- Juris Doctorate from an accredited institution required.
- Substantive legal knowledge and experience in areas of market access, government pricing, contracting, federal and state laws impacting pricing and access, antitrust, state pricing transparency and related areas.
- At least ten (10) years of legal experience, including time in or advising pharmaceutical companies.
- Ideal candidate is curious, self-motivated, and comfortable operating in a fast-paced, dynamic environment while proactively taking on new challenges.
- Experience navigating global, matrixed organizations and building alignment across functions, geographies, and leadership levels.
- Demonstrated ability to lead, develop, and inspire high-performing teams with sound judgment and strong leadership capabilities.
- Strong collaborator with the ability to build trusted relationships and work effectively with senior leaders and cross-functional partners.
- Excellent oral and written communication skills, with the ability to convey complex legal and business issues clearly to varied audiences.
Eligibility Requirements: - Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
