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.

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.