Associate Director, Aesthetics Clinical Development

About the role

The Associate Director, Clinical Development will have regional and/or global responsibilities. They lead the design, development, evaluation, planning and execution of clinical studies and ensure scientific integrity and interpretation of study data from a clinical development program. They provide medical and/or scientific direction to project/study teams and may 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.

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.
• Reviews, interprets, and communicates accumulating data pertaining to safety and efficacy of the asset.
• Oversight of study enrollment and overall timelines for key deliverables.
• May lead 0-5 employees in a matrixed environment.
• Engages external experts and investigators within the therapeutic area.
• Interacts with and coordinates appropriate scientific activities with internal stakeholders (i.e. medical affairs, commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to planned and ongoing 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.
• Initiates research projects compatible with 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.
• Ensures the review of clinical data, including protocol deviations.

Qualifications

• Advanced education (e.g., MD, DO, PhD, PharmD, or MA with relevant experience) preferred.
• At least 7 years of clinical development experience, preferably in the successful development of novel medical devices in Aesthetics with similar product profiles as those in development by AbbVie.
• Knowledge of regulatory requirements governing clinical trials, along with experience in the design and successful execution of registration-track protocols leading to regulatory submission.
• Direct experience with regulatory bodies (US and Global).
• Proven ability to collaborate effectively in a cross-functional setting.
• Excellent oral and written English communication skills and demonstrable evidence of being a motivated and successful self-starter.
• Experience in international markets is highly desirable.