Senior Counsel, Clinical R&D

AbbVie is searching for an in-house Senior Counsel for our Clinical Research & Development Legal team. This position will be based in our North Chicago headquarters location with a hybrid work model (on site 3+ days/week).

The successful candidate will become a key partner to support clinical research in the development of novel medicines with a remarkable impact on patients. The Senior Counsel will be an integral part of a team of attorneys and paralegals providing strategic legal and business advice in support of AbbVie’s Global R&D organization.  For candidates with strong leadership and strategic thinking skills, this role provides the opportunity to work with research & development teams and other corporate functions, including intellectual property, regulatory affairs, global privacy, and ethics & compliance. In this role, the Senior Counsel will be expected to interact regularly and effectively with research & development management, internal clinical study teams, business stakeholders, and third-party partners. They must be creative, strategic, and focused on the timely and successful conclusion of clinical trials studying the world’s most innovative therapeutics.

Responsibilities:

The Senior Counsel, Clinical R&D, will be responsible for identifying and resolving complex legal issues regarding the design and scientific objective of clinical trials, the regulatory submission of data resulting therefrom, and the agreements relating to study conduct. The responsibilities of the Senior Counsel, Clinical R&D, will include:

• Advising the AbbVie Clinical Development organization in connection with global research activity from initial concept and trial design through all phases of clinical development, including the legal regulatory implications of company decision-making activities regarding the design and execution of clinical trials. 
• Clearly communicating advice on complex situations that arise from clinical research, including advice incorporating FDA legal standards and expectations regarding studies needed to support product approvals,  patient privacy and rights, data integrity, site and investigator non-compliance, fraud & abuse, and digital health.
• Drafting and negotiating a variety of agreements, including collaborative research agreements and other transactions in furtherance of clinical trial operations.
• Providing clear advice to clients, including legal leadership, focused on maximizing the potential of our pipeline.
• Serve as recognized source, for both management and other AbbVie attorneys, of innovative ideas in complex areas of regulatory law, business, technology, and research.

Requirements:

• JD degree from an accredited law school, state bar admission (specific state admission not required).
• Experience in advising on pharmaceutical clinical development matters, including fluency with (1) medical and scientific research concepts and terminologies critical to the successful design and execution of studies to support approval of FDA-regulated products, and (2) FDA laws and regulations impacting clinical trial research, such as those relevant to the availability of non-patent regulatory exclusivities,  pediatric plan design and execution, and regulatory approval standards.  
• Ability to support the achievement of pharmaceutical business objectives by providing clear and practical counsel, evaluating and managing risk, and managing complex projects to meet deadlines.
• Ability to use legal training to maximize business opportunities.
• Excellent legal analysis skills, crisp and concise communication skills, and ability to identify and quickly address material issues. 
• 7 or more years of relevant experience. Some in-house experience preferred.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.