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Senior Director, Corporate Counsel — US Market Access & Government Contracts
Job Description
The Senior Director, Corporate Counsel will primarily serve as legal counsel to the Company's market access function, providing legal strategy, advice, and contracting support for market access initiatives related to Company products. The role will work closely with market access, commercial, sales, and other business teams on market access strategy, payer and pharmacy benefit manager ("PBM") arrangements, payer and PBM contracts, specialty pharmacy and provider agreements, pharmaceutical distribution channels, contract operations, government pricing, reimbursement, and related regulatory and compliance issues. This role is responsible for providing legal counsel, developing legal strategy, and negotiating terms for government-supported agreements. The Senior Director will work collaboratively with internal and external senior stakeholders to provide cohesive legal direction in support of Company goals. Lastly, the Senior Director, Corporate Counsel may also provide legal support to other business functions and on additional matters as needed. Responsibilities Draft, review, and negotiate contracts related to market access, including payer, specialty pharmacy and provider contract discount agreements, distribution agreements, and licensing deals. Support litigation and dispute resolution related to market access and reimbursement issues. Identifying potential legal risks associated with patient services and payer, specialty pharmacy and provider contracts and developing strategies to mitigate them Draft, review and negotiate various agreements to support manufacture, supply, commercialization and marketing/sale of pharmaceutical products, including manufacturing and supply agreements, wholesaler/distribution agreements, master services agreements and related statements of work, and agreements with market access and managed care entities Provide substantive legal advice and strategy on all laws and regulations pertaining to the development, manufacture and commercialization of pharmaceutical products, with particular emphasis on market access and payer agreements, patient support services, product liability, and how such laws relate to and impact complex corporate transactions and commercial arrangements with third parties Provide legal support, develop legal strategy, and negotiate relevant terms related to government-supported agreements with Department of Defense, (e.g., United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and Medical CBRN Defense Consortium (MCDC) projects), and Biomedical Advanced Research and Development Authority (BARDA) agreements and consortia (e.g., RRPV, PBS, BIOMAP) Prepare and implement compliance matrices and flow-down terms templates for government-supported agreements Draft, review and negotiate contracts to implement government-supported agreements, ensuring terms are compliant with governing agreements Juris Doctor (JD) from an accredited law school. Active license and good standing to practice law in at least one U.S. jurisdiction. This position exercises independent legal judgment and leads assigned legal matters within established Company policies and delegated authority. The role advises business leaders on legal risk and available options, aligns with relevant legal and compliance colleagues, and escalates material risks or matters requiring approval to the appropriate legal leader. Ability and willingness to participate in calls and video meetings with colleagues in Japan and Europe, which may occur early in the morning or later in the evening considering the time differences. Ability and willingness to travel approximately 5% of the year both domestically and internationally Must permanently reside a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per week. Advise on potential legal issues related to customer contracting, pricing and price reporting, including FD&CA and anti-kickback Provide legal support for business development activities, including performance of due diligence focusing on regulatory, promotional activities, social media and patient support services, and review and negotiation of related terms of business development transaction agreements Identify, allocate and/or mitigate legal risk in all matters affecting Shionogi, with particular emphasis on risks related to government contracts and agreements with market access and managed care entities Review and interpret existing contracts to advise business partners on contract requirements in an effort to ensure timely performance by Shionogi and counterparties Other duties as assigned Minimum Job Requirements Minimum of 10 years of substantive pharmaceutical and/or health care legal experience, preferably within: An in-house legal department, and/or A law firm with significant practice relating to market access Prior experience in interpreting and analyzing relevant pharmaceutical regulations and providing strategic advice to medical, commercial and business teams. Experience in handling investigation(s) and litigation(s) directly or with outside counsel. Demonstrated experience handling complex legal issues and analysis. Strong business judgment and ability to balance legal risk with commercial objectives. Preferred Experience working with certain divisions of the US government funding drug research, development and manufacturing. Competencies Excellent analytical skills. Clear, concise communication with both legal and non-legal stakeholders. Strong organizational skills and ability to manage competing priorities under tight deadlines. Pragmatic, solution-oriented approach to legal problem-solving. High degree of professionalism, discretion, and integrity. Ability to work effectively with business partners and in-house attorneys in the U.S. and Japan to ensure alignment on legal and compliance risks. Strong business judgment and ability to balance legal risk with commercial objectives. Strong negotiation skills and ability to assess contractual implications and appropriately allocate risk. Ability to independently manage assigned legal matters and recognize when consultation, escalation, or approval is needed. Essential Physical and Mental Requirements Ability to articulate clearly and conduct verbal presentations with large and small audiences. Ability to travel via automobile and/or airplane. Ability to view video display terminal images < 18" away from face for extended period of time - up to four (4) hours at a time. Ability to operate a computer keyboard and telephone. Ability to sit for extended periods of time - up to four (4) hours at a time. Ability to lift, tug, pull up to fifteen (15) pounds. Disclaimer The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.
Benefits
- Dental Insurance