Associate Director, Legal – Healthcare

Main Purpose of Job:

The primary purpose of this role is to leverage emerging expertise and subject matter knowledge in the field of healthcare law to address significant and unique complex issues, aligning work with the wider Immunocore’s strategy. The individual will interpret internal and external business challenges, recommend best practices, and identify new solutions to improve products and processes. They will make timely, tough decisions, effectively dealing with ambiguity and limited information

As Associate Director, you will provide strategic legal advice and practical counsel to the US Commercial, Medical, Regulatory, and associated support functions on a broad array of strategic and tactical projects within a highly regulated environment. This position will report to the Senior Director, Legal – Healthcare. The ideal candidate will have prior experience counselling prescription drug companies on legal issues relating to patient support, advertising and promotion, scientific exchange, interactions with healthcare professionals, anti-bribery and corruption, False Claims, and other related topics.

The incumbent will be expected to maintain strategic awareness of the market, competitive landscape, and opportunities, understanding the impact of their decisions on short-term and long-term results. They will interact proactively with key stakeholders, influencing, negotiating, and persuading on difficult concepts.

Key Responsibilities:

• Advise business partners on various Commercial, Medical, Regulatory, and associated support function initiatives in a way that advances the company’s strategy while addressing legal risks and protecting the company’s integrity and reputation.
• Provide legal advice and counsel on advertising and promotion strategies and activities, including the use of social media, disseminating scientific information, product development and labelling, product liability, healthcare fraud and abuse, and other matters relevant to the development, manufacture, and commercialization of prescription drugs.
• Draft, review, and negotiate various commercial agreements and arrangements related to primary areas of support.
• Closely collaborate with members of the Compliance team to ensure business operations in line with Immunocore policies and industry laws, rules, and regulations.
• Serve as a member of various cross-functional teams, including the US Legal, Medical, and Regulatory Review Committee (i.e. – promotional review committee).
• Act as a subject matter expert on matters relating to healthcare law and monitor and communicate to the organization significant legal developments, legislation, and regulatory rulings that may affect the company.
• Handle a broad range of miscellaneous legal tasks on an ad hoc basis.
Supervisory Responsibility (If applicable):
• N/A

Education, Experience and Knowledge:

Essential Qualifications:

• JD from an ABA accredited law school
• Member of state bar
• 5-8 years of related or equivalent experience advising clients on legal matters in a life sciences setting
• Outstanding ability to effectively communicate sound legal advice to lawyers and non-lawyers alike
• Excellent analytical and problem-solving skills
• Recognized as an emerging subject matter expert and advisor on statutes, regulations, and guidance applicable to commercial, development, and medical affairs activities, including, but not limited to, the Federal Food, Drug, and Cosmetic Act, ABAC laws and regulations, OIG guidance documents and advisory opinions, the Anti-Kickback Statute, the False Claims Act, the PhRMA Code, and other relevant codes.
• Experience serving on a promotional review committee.

Preferred Qualifications:

• Seeking a self-starter and motivated learner with a strong work ethic and excellent interpersonal skills who is a strong communicator, enjoys working collaboratively and cross-functionally on teams, as well as independently, proactively solves problems, thrives in a fast-paced and dynamic environment, is eager to take on new challenges.
• Comfortable operating in the “grey” or areas of ambiguity.

Other:
• Role is based out of our Gaithersburg, MD or Conshohocken, PA offices. Office attendance is expected.
• Occasional domestic travel may be required.