Associate Director, Aesthetics Clinical Development

Job Description 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 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. Designs Clinical Development Plans including early translational activities to mature product life cycle strategies. Conducts and reports clinical trials in line with the development, regulatory and commercial strategy. Reviews, interprets and communicates accumulating safety and efficacy data. Along with Clinical Operations, oversees study enrollment and overall timelines for key deliverables. Leads 0-5 employees in a matrixed environment. Manages external expert and investigator engagement within the therapeutic area. Coordinates scientific activities with internal stakeholders (medical affairs, commercial, clinical operations, discovery, statistics, regulatory, etc.) related to planned and ongoing studies or projects. Assists in scientific education of investigators, clinical monitors, and global project team members related to the therapeutic area. Stays current on professional information and technology through conferences or literature and acts as a subject matter expert. Represents AbbVie at external meetings including investigator meetings, scientific association meetings, and partner discussions. Ensures compliance with regulatory requirements for clinical studies. Coordinates and develops information for reports submitted to the FDA and global regulatory authorities. Initiates research projects compatible with the project plan goals and drives them to completion, resulting in high‑quality publications. Leads cross‑functional sub‑teams overseeing defined sub‑projects within the therapeutic area. Is accountable for the scientific validity, integrity and overall quality of the Clinical Development Plan and all clinical content, including protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions and publications. Collaborates with Clinical Operations to lead the scientific and clinical aspects of executing the defined Clinical Development Plan, acting as a key contact for the Clinical Trial Team regarding scientific and clinical development aspects. Ensures review of clinical data, including protocol deviations. Qualifications Advanced education (MD, DO, PhD, PharmD, or MA with relevant experience) preferred. At least 7+ years of clinical development experience, with a track record of successful development of novel medical devices in Aesthetics if applicable. Knowledge of regulatory requirements governing clinical trials and experience in designing and executing registration‑track protocols leading to regulatory submission. Direct experience with US and global regulatory bodies. Proven ability to collaborate effectively in a cross‑functional setting. Excellent oral and written English communication skills and evidence of being a motivated and successful self‑starter. Experience in international markets is highly desirable. Benefits Paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. Eligible for participation in long‑term incentive programs. AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving the community. Equal Opportunity Employer/Veterans/Disabled. #J-18808-Ljbffr Initial Therapeutics, Inc.