Director I, Aesthetics Clinical Development

Role Summary

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. This position is based onsite in Irvine, CA.

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.

Qualifications

• Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) preferred.
• Ability to provide input and direction to clinical research teams with minimal supervision.
• Strong cross-functional collaboration and leadership skills in a team-matrixed environment.
• Experience managing program budgets, timelines.
• Demonstrated ability to select, contract and manage vendor, ensuring high-quality and on time deliverables
• At least 5 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Knowledge of clinical trial methodology, regulatory and compliance requirements in Aesthetic Medicine.
• Ability to interact externally and internally to support global scientific and business strategy. Must possess excellent oral and written English communication skills.