Job Summary (Primary function)
The Senior Director, Legal – US Commercial provides regulatory, transactional, and general legal support to the U.S. commercial organization. The attorney will support various aspects of Market Access activities, including trade and distribution, contract strategy, communications, and patient access and support.
Essential Functions of the Job (Key responsibilities)
Establishes a rapport and a constructive working relationship with business unit management and personnel at all levels to encourage and continue the proactive use of in-house legal counsel.
Provides day-to-day legal advice and transactional support regarding a wide range of activities and programs related to the commercial and scientific activities in the United States, including:
Assess current legal trends and enforcement priorities in the rapidly evolving Market Access areas and communicate updates to clients in a timely fashion.
Analyze and apply knowledge of the various statutes, regulations and guidance documents applicable to proposed Market Access activities.
Draft, review, and negotiate a variety of contracts including, but not limited to, master service agreements, consulting agreements, licensing agreements, and confidentiality agreements. As assigned, manage and/or direct the contracting work of contract specialists and oversee Legal’s responsibility for contract administration for assigned business or medical/scientific areas.
Identify training needs and provide legal training to employees and consultants.
Identify, calibrate, and communicate nature and extent of risks associated with commercial and scientific activities for clear and consistent decision-making.
Collaborate cross-functionally to proactively manage risks by understanding business goals and developing solutions with partners to achieve those goals.
Build constructive working relationships and operates as an active member of both Global Legal and US commercial teams.
Demonstrate leadership by seeking to improve ways for Legal to operate with an eye towards gaining efficiencies or similar enhancements.
Handle such other legal matters as may be assigned by this person’s direct supervisor and/or the head of the legal department.
Qualifications (Minimal acceptable level of education, work experience, and competency)
J.D. or equivalent as well as bar admission and active membership in good standing in at least one United States state bar.
7+ years of experience working as in-house legal counsel with a pharmaceutical or a biotechnology company, or in the life sciences practice group of a law firm. Legal experience addressing Market Access-related legal issues in a pharmaceutical company is preferred.
A solid working knowledge of pharmaceutical Market Access practices as well as the statutes, regulations and guidance documents applicable to these activities (e.g., federal and state anti-kickback statutes, government price reporting statutes and regulations (Medicaid, 340B, Veterans Healthcare Act), OIG guidance documents and opinions, the Federal False Claims Act, and the Food, Drug and Cosmetic Act, regulations and guidance documents).
Experience launching a drug product, as well as supporting sales and marketing with advertising, promotion, and labeling issues is preferred.
Experience providing legal advice for a wide range of regulatory matters, including but not limited to, FDA and OIG regulations applicable to the pharmaceutical industry.
Strong written and verbal communications skills, including the ability to communicate concisely, integrate legal and business knowledge, and provide balanced advice regarding risks.
Strong attention to detail. Proficient with Microsoft Office suite of products.
Ability to manage multiple tasks simultaneously, handle highly sensitive information appropriately, and flourish in a fast-paced environment.
Excellent interpersonal skills, with the ability to interact in a professional manner with employees at all levels of the organization.
Ability to travel within the United States, up to 10% of time.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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