Overview

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.

o Enable consistent decision-making by assessing, calibrating, and clearly communicating risks tied to commercial and scientific activities.

o Strengthen capability and consistency by identifying training needs, delivering legal training for employees/consultants, and overseeing creation of enduring guidance materials to standardize legal reviews.

o Show 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.

o Understand 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:

o Provide legal support for product launches, including review of core claims, campaign strategy, speaker programs, advisory boards, patient initiatives, and digital engagement models.

o Advise on lifecycle management strategies including new indications and evolving promotional claims.

o Review promotional and educational materials involving the marketing of the Company's products via the Medical, Legal, Regulatory (MLR) process.

o Review nonpromotional materials communicating disease state and similar nonpromotional information to healthcare professionals and patients.

o Provide legal input on sales and marketing initiatives, commercial operations, and medical affairs activities.

o Assess 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 US Legal 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.