Reference #: 5146
Overview
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
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)
Develops a thorough understanding of and familiarity with the company's business, its operations, its people, products, markets, facilities, customers and competitors and utilizes that knowledge in working with stakeholders to mitigate risks.
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:
oDraft, review, negotiate, and manage a robust set of contracts related to the distribution, dispensing, and reimbursement of pharmaceuticals, as well as services that relevant customers may provide.
oReview promotional and educational materials involving the Company's products via the Medical, Legal, Regulatory (MLR) process.
oAssess current legal trends and enforcement priorities in the rapidly evolving Market Access areas and communicate updates to clients in a timely fashion.
oAssess proposed service arrangements with Market Access customers and vendors.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.
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You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the @types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
We appreciate, celebrate, and thrive on one another's differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.
