Senior Medical Director, Clinical Development

About the role

In collaboration with the Exelixis clinical teams, the Senior Medical Director leads and executes early and/or late stage clinical trials for oncology products in development. Participates in the design/planning of clinical studies and helps interpret study results. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators for research studies. Responsibilities also include adverse event reporting and safety event monitoring. Coordinates and develops reporting information for reports submitted to the FDA. Monitors adherence to protocols and determines study completion.

Responsibilities

• Support the establishment of clinical trial strategies for oncology products in development.
• Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
• Act as medical monitor for company sponsored trials (including but not limited to assessment of eligibility and safety