Executive Director, Legal - US Commercial

Reference #: 5977

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 Executive Director, Legal - US Commercial is a strategic legal advisor and partner to the US commercial teams (excluding Market Access) across all therapeutic areas, as well as other key client groups. In this role, they provide proactive counsel and balance business enablement with regulatory and risk management. Essential Functions of the Job(Key responsibilities) Partner with US Commercial and Global Product Strategy leadership to support launch excellence, lifecycle management strategy, and evolving promotional models. Anticipate and advise on emerging legal, regulatory, enforcement, and industry trends impacting US commercialization. Provide executive-level risk assessments and recommendations to senior leadership, including participation in leadership or governance forums as appropriate. Serve as an established expert with strong relationships across the US Commercial team to encourage and continue the proactive use of in-house legal counsel. *Drive consistency across US Legal by sharing learnings, developing reusable, useful guides, and aligning approaches on product promotion, HCP engagements, scientific communications, and patient advocacy. oEnable consistent decision-making by assessing, calibrating, and clearly communicating risks tied to commercial and scientific activities. oStrengthen capability and consistency by identifying training needs, delivering legal training for employees/consultants, and overseeing creation of enduring guidance materials to standardize legal reviews. oShow leadership by finding ways to make Legal operate more efficiently, reduce duplication, and partner with other functions to improve processes. *Build and sustain a high performing legal team by establishing clear priorities and expectations, providing guidance and mentoring, and ensuring high-quality, timely legal support for the business. Drive engagement, development, inclusion and collaboration across the team. oUnderstand review workloads and re-allocate work as necessary, taking advantage of span of US Legal across both Hematology-Oncology and Dermatology. *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: oProvide legal support for product launches, including review of core claims, campaign strategy, speaker programs, advisory boards, patient initiatives, and digital engagement models. oAdvise on lifecycle management strategies including new indications and evolving promotional claims. oReview promotional and educational materials involving the marketing of the Company's products via the Medical, Legal, Regulatory (MLR) process. oReview nonpromotional materials communicating disease state and similar nonpromotional information to healthcare professionals and patients. oProvide legal input on sales and marketing initiatives, commercial operations, and medical affairs activities. oAssess proposed engagements of healthcare professionals, patients, and other consultants and vendors to perform services on behalf of Incyte Corporation. Draft, review, and negotiate a variety of contracts including, but not limited to, master service agreements, consulting agreements, and confidentiality agreements. Socialize information concerning legal, regulatory, and business developments within USLegal team, wider Legal function, and with US business clients. *Handle such other legal matters as may be assigned by direct supervisor and/or the head of the legal department. Qualifications (Minimal acceptable level of education, work experience, and competency) J.D. and active membership in at least one state bar; ability to qualify as in-house counsel in PA and DE. 10+ years relevant legal experience, including 4+ years in-house supporting pharma sales/marketing (preferred). Strong knowledge of pharma marketing/communications and key compliance frameworks (FDCA/FDA, AKS/OIG, HIPAA, Sunshine Act, PhRMA Code). Strong business acumen and understanding of pharmaceutical commercialization strategy. Demonstrated executive presence and ability to influence senior leadership. Experience advising on advertising, promotion, labeling, including promotional review committee/PRB participation and product launches. Experience counseling on legal risks arising from pharmaceutical regulatory matters, including FDA and OIG requirements. Proven ability to manage multiple priorities in a fast-paced environment. Sound risk-based judgment, including with executive-level decisions. Strong attention to detail, collaboration, and ability to work independently in a matrixed organization. Excellent written, verbal, and presentation skills; communicates concise, practical advice and learns quickly. Ability to travel up to 10% within the U.S.

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. We Respect Your Privacy Learn more at: 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.

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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.