Associate Director, Clinical Development

Description
Associate Director, Clinical Development

Los Angeles, CA / Hybrid

Our Values

· Integrity

· Intelligence

· Initiative

What You Will Do

Lead drafting of clinical trial protocols for new indications
Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s)
Interpret and communicate clinical trial data
Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings
Identify new clinical research opportunities

What We Look For

Multi-year experience designing clinical trials and drafting protocols for US FDA
In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials in all phases of development, especially Ph1b and 2/3 registrational trials
Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
Prior experience of regulatory interactions, authoring filing IND or BLA experience
MD (or equivalent), PhD, PharmD or other Bachelors/higher degree