Scientific Director, Clinical Development Eye Care

---

Job description

Job Description

Hybrid (3x per week onsite) in Irvine, CA strongly preferred.

In conjunction with Clinical Leader, designs directs, plans, executes, and interprets clinical trials/research and data collection activities. The successful candidate will utilize scientific methods for design and implementation of clinical protocols, and data collection systems to enable final reports. Coordinates clinical team activities needed to produce clinical study reports.

A successful applicant may recruit clinical investigators and negotiate study design. Responsibilities also may include directing the execution of human clinical trials, phase I - IV for company products under development, Coordination and development of information for reports submitted to the FDA and Global Regulatory Authorities. The successful applicant will monitor adherence to protocols and determine study completion. Also, this individual will act as a consultant/liaison/resource with other corporations when working under licensing agreements.

Responsibilities:

Assists in the design of clinical studies and clinical development plans. Responsibilities may extend from early translational development activities to mature product life cycle strategies.

In conjunction with Clinical Leader, designs, conducts and reports clinical trials in line with the development, regulatory and commercial strategy.

May lead 0-5 employees in a matrixed environment. May be responsible for opinion leader development within the therapeutic area Interacts with and coordinates appropriate scientific activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc ) as they relate to on-going clinical studies or projects.

Assists as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.

Assists in scientific education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences or medical literature and acts as a therapeutic area resource.

Represents AbbVie at external meetings including investigator meetings, scientific association meetings, partner discussions, etc.

Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements

May lead cross functional sub-teams responsible for defined sub-projects within the therapeutic area (individual publications or study collaborations).

May initiate research projects compatible with project plan goals and drive them to completion, resulting in high quality publications

<!– job description page –>