Director I, Clinical Development- Aesthetics

Job Opportunity At AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.

The Director I 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 toxin 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.
• 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 in Irvine, CA.

Qualifications :

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.