Senior Director, Clinical Science (Brisbane Office Preferred or Remote)

Overview

The Senior Director, Clinical Science will be an essential contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on program-specific activities. The Senior Director, Clinical Science will drive the design, planning, and implementation of study protocols for assigned investigational products and will play a key role in supporting related regulatory activities. This role will work on cross-functional program development and study management teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication to both internal and external stakeholders. This individual may also help support internal process improvement initiatives within the clinical department.

In Short

• Oversee the conduct of clinical studies and operational feasibility.
• Perform medical and safety/efficacy data reviews.
• Provide organizational support for Data Monitoring Committees.
• Author protocols and clinical study reports.
• Interact with internal and external stakeholders.
• Act as a recognized clinical expert.
• Write and review content for scientific meetings.
• Conduct literature reviews.
• Line management of junior clinical scientists.

Requirements

• PhD, PharmD, MD or equivalent in health science.
• 12+ years of experience in a pharmaceutical, CRO or biotechnology company.
• Experience in oncology or oncology immunotherapy clinical trials.
• Late-stage drug development and BLA/NDA filing experience.
• Experience with data analysis and interpretation.
• Ability to evaluate and present complex scientific data.
• Excellent communication skills.
• Ability to handle multiple projects and attention to detail.

Benefits

• Competitive market-based salary.
• Participation in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.