Director/Senior Director, US Legal - Commercial & Market Access

Job Description

Job Overview:

Henlius is a global, innovation-driven, and patient-centric biopharmaceutical company committed to delivering high-quality biologic therapies to patients worldwide. As Henlius expands in the United States and prepares for its first U.S. commercial launch, anticipated in 2027, we are seeking an experienced, hands-on Director/Senior Director of US Legal, specializing in Commercial and Market Access. Location of hybrid work will be Jersey City, New Jersey or Milpitas, California.

This role will provide legal support for commercial operations by negotiating a broad range of healthcare and corporate agreements, advising on market access, reimbursement, regulatory and pricing compliance matters, maintaining commercial policies and controls, and partnering cross-functionally to support business objectives and compliance.

Job Functions/Responsibilities:

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• Draft, review and negotiate a wide variety of commercial contracts including payer and PBM agreements, GPO agreements, distribution agreements, pharmacy agreements, rebate agreements, service agreements, and other corporate agreements
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• Support the company’s commercial organization and provide legal advice and counsel on
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• Market access and reimbursement issues
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• Statutory and regulatory obligations under Medicaid, Medicare, 340B program, Veterans Health Care Act
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• Government pricing, including price reporting compliance policies and reasonable assumptions documents
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• Advertising, promotional, sales and marketing assessments
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• Maintain and enhance commercial policies, procedures, and internal controls
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• Partner cross functionally with clinical, commercial, market access, finance, and compliance teams
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Qualifications:

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• Juris Doctor degree with 8+ years relevant legal experience; prior in-house healthcare or pharmaceutical experience required
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• Licensed to practice law in New Jersey, California or be eligible for licensure as a registered in-house counsel in either state
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• Demonstrated experience drafting, reviewing, negotiating, and counseling on complex market access, rebate, distribution, administrative services, patient support, and value-based contracts.
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• Strong knowledge of pharmaceutical regulatory enforcement trends, market access strategy, payer and PBM-related issues, other market access contracts, government pricing requirements, regulatory and compliance issues, the FDCA, the False Claims Act, federal and state fraud and abuse laws, and antitrust laws
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• Experience advising on statutes, regulations, and guidance documents applicable to market access activities, including Medicaid, 340B program, Veterans Administration, federal and state anti-kickback statutes, state drug pricing transparency laws, OIG guidance documents and advisory opinions, the False Claims Act, and the PhRMA Code
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• Excellent interpersonal and conflict resolution skills, and ability to work in highly collaborative, team-oriented environment
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• Excellent understanding of healthcare laws and proven experience in applying them to complex business situations
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About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 10 products have been approved for marketing worldwide, and 5 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, denosumab Bildyos® and Bilprevda®, and pertuzumab Poherdy®. What's more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

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