Description:

The Director Legal, U.S. & Global Commercialization will be a key member of the growing A Biotechnology Company commercialization legal team and will be integral to the anticipated launches of A Biotechnology Company first oncology products in the United States and other markets. This role will support multiple business partners across U.S. and global commercialization and commercialization-adjacent functions, including Marketing, Market Access, Medical Affairs, Corporate Communications, and Patient Engagement & Advocacy. This attorney will have the opportunity to make a meaningful impact on a growing commercialization organization. This position is an ideal situation for a legal professional who is energized by close partnerships with business stakeholders. This role reports to the Vice President Legal, Global & Market Commercialization.

This is a hybrid position based in Berkeley Heights, New Jersey, where our U.S. commercialization organization is based. There may be occasional travel to our U.S. headquarters in Cambridge, Massachusetts and our global headquarters in Mainz, Germany.

Your main responsibilities will include:

Provide legal advice on a broad range of commercialization-related subject matter in support of anticipated launches of oncology products in the U.S. market and globally, including sales and marketing strategy, market access activities, patient support programs, medical affairs initiatives, media campaigns, and interactions with patients and patient advocacy organizations.
Advise on commercialization-related contracts and engagements, including distribution agreements, GPO agreements, rebate agreements, specialty pharmacy agreements, vendor agreements, service agreements, consulting agreements, and sponsorships.
Serve as a legal representative on cross-functional Medical-Legal-Regulatory (MLR) review teams to provide legal advice on promotional and non-promotional communications including sales and marketing materials, market access materials, patient support program information, disease education, scientific exchange, press releases, and clinical trial recruitment activities.
Represent Legal on cross-functional teams with responsibility for identifying legal issues and considerations, evaluating possible options and solutions, and providing recommendations to achieve business objectives and mitigate legal risks.
Actively share knowledge and collaborate with colleagues across Legal Department teams to facilitate consistent and cohesive advice to internal clients.
Proactively identify and inform internal clients of important new laws, regulations, and enforcement trends relevant to the industry.

What you have to offer:

Juris Doctor from an accredited law school; active membership and in good standing in a state bar and either admitted to the New Jersey bar or eligible for admission to the New Jersey bar as in-house counsel.
Minimum 7 years prior legal experience, with a strong preference for 3+ years in-house pharmaceutical or biotech experience counseling a U.S. commercialization function on relevant subject matter including the Anti-Kickback Statute and False Claims Act. Oncology experience and experience with launching a product in the U.S. market are helpful.
Familiarity with pharmaceutical/biotech commercial contracting is preferred.
Experience supporting global commercialization teams is desirable.
High degree of personal ethics, integrity, and accountability.
Practical, collaborative, clear, creative, and solution oriented.
Ability to prioritize, meet deadlines, and exercise sound judgment with critical thinking skills and thrive in a dynamic environment.