Head of Legal

GC Biopharma USA, Inc.; Teaneck Township (NJ); Presencial; USD 247.000 - 333.000; Jornada completa

Descripción de la vacante

GC Biopharma USA, Inc. is seeking a Head of Legal to provide comprehensive legal support across commercial, regulatory and operational matters for its branded and biologic portfolio.

Reporting to the Chief Operational Officer, this role serves as the key legal advisor to the business and Compliance on healthcare law compliance and market access strategies. The role covers contract drafting and negotiation, pricing strategy, corporate governance, regulatory guidance, privacy, promotional review,

Formación

• JD required and bar admission in good standing or eligibility for in-house status in New Jersey.
• Minimum of 10 years post-JD experience in life sciences, either in-house or at a law firm.
• Expertise in healthcare laws applicable to market access activities, including Medicaid, 340B, and anti-kickback statutes.
• Advanced drafting and negotiating skills with exceptional attention to detail.

Responsabilidades

• Provide pragmatic, solutions-oriented legal counsel on payer and distribution contracting strategies.
• Counsel on compliance and risk mitigation for market access initiatives and payer disputes.
• Draft, review, and negotiate strategic, high-value and non-standard agreements, including PBM, GPO, specialty pharmacy, distribution, and vendor contracts.

Conocimientos

Legal knowledge

Negotiation

Communication

Project management

Educación

J.D. from ABA-accredited law school

Herramientas

MS Word

PowerPoint

Excel

Descripción del empleo

At GC Biopharma USA, our people are at the heart of everything we do. We’re driven by a mission that matters: developing innovative plasma-derived medicines that help improve patients’ lives. When you join our team, you become part of a company with deep roots, a growing US presence, and a shared commitment to making a meaningful difference for the patients we serve.

About the Role

The Head of Legal is responsible for providing comprehensive legal support across a variety of commercial, regulatory and operational matters related to the Company’s branded and biologic product portfolio. Reporting to the Chief Operational Officer, this role serves as the key legal advisor to the business, advising the business and the Compliance department on compliance with healthcare laws while driving innovative market access strategies and supporting the Company’s marketing and promotional review initiatives.

Responsibilities

Legal Counseling:

• Provide pragmatic, solutions-oriented legal counsel on payer and distribution contracting strategies.
• Counsel on compliance and risk mitigation for market access initiatives, including copay programs, discount strategies, and payer customer disputes.
• Evaluate potential service contracts with supply chain partners, including those involving bona fide service fees.

Pricing Strategy:

• Propose and evaluate pricing strategy, including WAC changes, discount and rebate structures.
• Provide guidance on pricing impact with respect to ASP, AMP and Best Price. Advise the Market Access team on the legal aspects of government pricing submissions and certifications, which Market Access prepares.

Contract Drafting & Negotiation:

• Supervise the Associate Director, Commercial Contracts, who owns day-to-day contract drafting, negotiation and administration.
• Draft, review, and negotiate strategic, high-value and non-standard agreements, and provide final legal sign-off on all commercial agreements, including PBM, GPO, specialty pharmacy, wholesaler, discount/rebate, distribution, value-based, vendor, and service agreements.
• Support the development and expansion of patient support programs across product portfolio from a legal and compliance perspective.

Corporate Support:

• Support corporate governance matters and maintain corporate records, filings and registrations.
• Select, manage and oversee outside counsel across all legal matters, including scope of work and budgets.

Regulatory Guidance and Fraud and Abuse Laws:

• Advise the business and the Compliance department on compliance with the Anti-Kickback Statute, False Claims Act, PhRMA Code, OIG guidance, Sunshine Act and other U.S. healthcare regulations.
• Advise on compliance with laws and regulations, including Medicare Parts B and D, 340b, Medicaid, Veterans Health Care Act, and state-specific drug pricing transparency laws.
• Manage the Company’s trademarks and coordinate with outside patent counsel to protect the Company’s intellectual property.

Privacy and Data Protection:

• Advise on HIPAA, state privacy laws and other data protection requirements, including as they apply to patient support programs.

Promotional Review and Training:

• Lead the advertising and promotional review (Ad/Prom) process for product(s), ensuring materials comply with applicable laws and regulations, including FDA promotional labeling and advertising requirements.
• Participate in the training and Medical-Legal-Regulatory (MLR) review process to support cross-functional teams in navigating compliance requirements.

Litigation and Dispute Resolution:

• Evaluate disputes with contracting partners, propose solutions and negotiate resolutions.
• Oversee outside counsel in litigation matters or ADR proceedings.

Government Inquiries and Investigations:

• Respond to subpoenas and government inquiries and investigations, in coordination with outside counsel.
• Advise the Compliance and Human Resources departments on whistleblower matters and internal investigations, including attorney-client privilege.

Investigate Initiated Research:

• Review and understand IIR proposals and associated funding requests.
• Draft and negotiate IIR contracts.

HR Support:

• Assist Human Resources Department with legal aspects of personnel-related policies and actions.
• Review employee contracts involving compensation, short- and long- term incentives, sales force incentive compensation arrangements and terminations.
• Oversee outside employment counsel and advise on the legal aspects of terminations, separations and employment disputes.

Cross-Functional Collaboration:

• Partner with business leaders to deliver aligned legal and regulatory guidance.
• Develop and deliver training programs to educate internal teams on legal requirements and Company policies.

Policy Advisory and Compliance Partnership:

• Analyze policy and regulatory developments, such as the Inflation Reduction Act, to guide business strategies.
• Advise the Compliance department and business owners on the legal requirements for standard operating procedures (SOPs) and policies, and review drafts for legal alignment.
• Advise the Compliance department on compliance-related initiatives, including advisory boards, patient support programs, and access strategies.
• Advise the Compliance department on legal risk assessments and audits, and on remediation of legal findings.
• Partner with the Compliance department, which owns the compliance program and monitoring, and escalera legal risks to leadership as appropriate.

Qualifications

Education: JD from an ABA-accredited law school and membership in good standing in New Jersey, or eligibility for authorized in-house counsel status in New Jersey.

Experience:

• Minimum of 10 years of post-JD experience in life sciences, either in-house or at a law firm.
• Expertise in healthcare laws applicable to market access activities, including Medicaid, 340B, and anti-kickback statutes.
• Advanced drafting and negotiating skills with exceptional attention to detail.
• Demonstrated ability to manage multiple projects and prioritize effectively in a fast-paced environment.

Other Knowledge, Skills, and Abilities:

• Business Acumen
• Critical Thinking & Analytical Skills
• Communication & Negotiation Expertise
• Team Collaboration & Conflict Resolution
• Proactive Problem-Solving

Preferred:

• In-house pharmaceutical legal experience.
• Knowledge of plasma products, FDA regulations, and market access strategies.
• Experience with compliance programs, patient support initiatives, and value-based contracting.
• Familiarity with intellectual property management and promotional review processes.
• Proficient in Microsoft Word, PowerPoint, and Excel.
• May work in a clean, pleasant, and comfortable office setting.
• Limited domestic travel.

Compensation

Salary range: $246,800–$333,000

Please Note: GC Biopharma USA reserves the right to change or modify job duties and assignments at any time. The above job description is not all encompassing. Position functions and qualifications may vary depending on business necessity.

GC Biopharma USA, Inc., is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law. GC Biopharma USA is committed to providing a workplace free of discrimination and harassment, and to ensuring equal opportunity in all aspects of employment, including hiring, promotion, compensation, and training.

Reasonable Accommodation

GC Biopharma USA is committed to providing reasonable accommodations to qualified individuals with disabilities during the application and interview process. If you need assistance or an accommodation, please contact [e-mail] .