Description:
Job Description:Overview:
A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity
Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.
Job Summary (Primary function)
The Director, Corporate Counsel – U.S. Commercial is responsible for providing regulatory, contracting and general legal support to the U.S. Commercial business unit to support the commercialization of Incyte's portfolio of approved drugs.
Essential Functions of the Job (Key responsibilities)
- Develop a thorough understanding of and familiarity with the company's business, its people, products, markets, facilities, customers and competitors and utilize that knowledge to counsel internal clients.
- Establish a rapport and a partnership with business leaders to build trust and drive proactive use of in-house legal counsel.
- Provide strategic counsel as well as day-to-day legal advice on a wide range of activities and programs related to commercialization, including:
- Review promotional and educational materials involving the Company's products via the Medical, Legal, Regulatory (MLR) process.
- Review communication and brand planning, including non-promotional communications.
- Draft, review, and negotiate a variety of contracts including, but not limited to: Master Services Agreements, consulting agreements, and confidentiality agreements.
- Identify and communicate risks associated with day-to-day operational business activities; train business partners on relevant legal issues.
- Partner with business leaders to proactively apply legal and regulatory framework to business activity by understanding business goals and developing alternative solutions to assist in the achievement of successful outcomes.
- Operate as an active member of legal and commercial teams, serving as the legal representative on cross-functional initiatives and projects as needed and assigned.
- Develop and maintain legal expertise on relevant enforcement and litigation trends for Incyte business practices and recommend corporate best practices accordingly.
- Demonstrate leadership by contributing to Legal Department efforts to improve the efficiency of its operations.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- J.D. degree as well as active membership in good standing in at least one United States state bar. Ability to obtain admission to Pennsylvania bar.
- At least 5+ years of legal experience working as in-house counsel or in the life sciences practice group of a law firm, with at least 2 years in-house legal experience in the pharmaceutical or healthcare industry.
- Solid working knowledge of pharmaceutical commercialization planning and the various statutes, regulations, and guidance applicable to these activities (e.g., the Food, Drug and Cosmetic Act, regulations and guidance documents; the federal and state anti-kickback statutes, regulations and OIG guidance documents and opinions; the Federal False Claims Act; the Prescription Drug Marketing Act and regulations; HIPAA and other privacy laws ; and ACCME policies and guidelines).
- Good general working knowledge of liability issues and contract preparation and negotiation.
- Strong written and verbal communications skills, including the ability to communicate concisely with clients, to integrate legal and business knowledge and to provide balanced advice regarding risks.
- Ability to manage multiple tasks simultaneously and to flourish in a fast-paced environment.
- Excellent interpersonal skills, with the ability to work well independently as well as part of a team.
- Experience supporting pharmaceutical advertising, promotion, and labeling issues is preferred.