Companion Diagnostic Lead (Manager To Associate Director)
By Duality Biologics At United States
Strong project management skills, including the ability to manage multiple projects simultaneously.
Oversee and manage external vendors and CROs involved in CDx development and validation studies.
Provide expert guidance and training to team members on regulatory requirements for companion diagnostics.
Thorough understanding of the U.S. FDA and EU regulatory requirements for in vitro diagnostic devices.
Demonstrated experience in guiding and supporting cross-functional teams in CDx development.
Knowledge of relevant diagnostic technologies and platforms used in companion diagnostic assays.