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Associate Director, Aesthetics Clinical Development

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Irvine, Irvine
Posted 2 months ago
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Job Description

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more.

With our own research and development team focused on driving innovation in aesthetics, we’re committed to providing the most comprehensive science-based product offerings available.

The Associate Director will provide direction and oversight to the design, planning and execution of research activities including but not limited to clinical trials in Aesthetic Medicine. Participate and lead cross-functional teams to generate, deliver and interpret high quality research and clinical data supporting aesthetic indications and overall asset program strategy. As a clinical development subject matter expert, author, edit and review key section of research protocols, reports and regulatory submissions.

Responsibilities:

  • Based on strong medical and scientific experience, knowledge of compliance and regulatory requirements, Allergan Aesthetics customers, markets, business operations and emerging issues , manage the design and implementation of research protocols for clinical development programs in support of the overall Product Development Plan. 
  • Oversees project-related education of investigators, study site personnel and AbbVie study staff.
  • Responsible for understanding and addressing applicable regulatory requirements related to the clinical studies, clinician reported outcomes, patient reported outcomes and global drug development. Specifically in the area of aesthetic development.
  • Contributes to design, analysis, interpretation, presentation and reporting of scientific protocols, Investigator Brochures, Clinical Study Reports, Clinician Reported Outcome Dossiers, regulatory submissions and responses and other program documents.
  • Contribute to the development of a rigorous, cross-functionally-aligned, vetted Integrated Evidence Plans in collaboration with matrix team members.
  • Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

The position is based onsite in Irvine, CA.

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