The Associate Director, Clinical Development will have regional and/or global responsibilities. Leads the design, development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data from a clinical development program. Provides medical and/or scientific direction to project/study teams. Should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members.

The position will be based in Irvine, CA with a hybrid schedule of 3 days in office. 

Responsibilities:

Under supervision of the Global Clinical Development Lead, designs, directs, executes, and interprets clinical trials/research and data collection activities in support of the overall Product Development Plan, within time, budget, and based on strong scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues. Collaborates with cross-functional teams to generate, deliver, report, and interpret high-quality clinical data supporting overall product scientific and business strategy, including monitoring adherence to protocols and ensuring correct endpoint data collection.

Under the appropriate supervision:

• Designs Clinical Development Plans. Responsibilities may extend from early translational development activities to mature product life cycle strategies.
• Designs, conducts, and reports clinical trials in line with the development, regulatory and commercial strategy.
• Has responsibility for review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the asset.
• Along with Clinical Operations, may be responsible for oversight of study enrollment and overall timelines for key deliverables.
• May lead 0-5 employees in a matrixed environment.
• May be responsible for external expert and investigator engagement within the therapeutic area.
• Interacts with and co-ordinates appropriate scientific activities with internal stakeholders (i.e. medical affairs, commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to planned and on-going clinical studies or projects.
• Assists in scientific education of investigators, clinical monitors, and Global Project Team members related to therapeutic area.  
• Keeps abreast of professional information and technology through conferences or medical literature and acts as a subject matter expert.
• Represents AbbVie at external meetings including investigator meetings, scientific association meetings, partner discussions, etc.
• Responsible for understanding the regulatory requirements related to clinical studies and accountable for complying with those requirements.
• May coordinate and develop information for reports submitted to the FDA and Global Regulatory Authorities.
• May initiate research projects compatible with project plan goals and drive them to completion, resulting in high quality publications
• Leads cross functional sub-teams overseeing defined sub-projects within the therapeutic area.
• Responsible and accountable for the scientific validity, integrity and overall quality of the Clinical Development Plan and all clinical content, including, but not limited to protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions, and publications associated with the clinical trials.
• Participates in the development of the Clinical Development Plan by contributing the scientific/clinical expertise for the strategy. Once completed, in collaboration with Clinical Operations, is responsible for and leads the scientific/clinical aspects of the execution of the defined Clinical Development Plan, acting as a key contact for the Clinical Trial Team(s) regarding the scientific/clinical development aspects of a project.
• Ensures the review of clinical data, including protocol deviations.