Since 1987, Vical Inc. has been focused on research and development of biopharmaceutical products based on our patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. In addition, we have gained access to enhancing technologies through licensing and collaborative agreements.
WHO ARE WE LOOKING FOR:
Clinical Project Manager
The candidate will be responsible for managing Phase 1-3 infectious disease vaccine trials for a small biotechnology company in San Diego, reporting to the VP, Clinical Vaccines. Responsibilities will include: (1) managing a Contract Research Organization (CRO) in the conduct of clinical trial(s), (2) fostering effective and collaborative interactions with the staff of multiple U.S. trial sites, (3) preparing operational plans for clinical trial execution, and (4) managing schedule, cost and performance (quality) to meet, if not exceed, company timeline/budgetary objectives and U.S. Food and Drug Administration (FDA) standards for subject safety and data integrity. Effective participation in project teams to ensure smooth trial enrollment and expeditious troubleshooting when operational issues arise. Apprise senior clinical management on trial status on a regular basis. Provide training and oversight to strive for Good Clinical Practice (GCP) compliance. Interface professionally and effectively with Company personnel to promote and enhance the morale and caliber of the clinical department.
In addition to the responsibilities described above, the candidate will:
•Remain current in the latest standards of clinical trial conduct
•Exhibit strong command of clinical operations
•Promote the use of Microsoft Project to schedule and monitor multiple interdependent tasks related to clinical trial execution
•Oversee multiple contracts and contractors, including a contract research organization (CRO)
•Demonstrate strong organizational and problem-solving abilities in addressing and rectifying operational issues
•Display quiet but firm approach in interacting with site investigators, study coordinators, vendors and contractors
•Exhibit excellent oral and written communication skills
•Perform effectively in a team environment, collaborating effectively with other departments such as Regulatory Affairs, and Quality Assurance
•Design trial documents including but not limited to clinical protocols, consent forms, case report forms, site study manuals, and project/tracking tools
Vical Incorporated researches and develops biopharmaceutical products based on its deoxyribonucleic acid (DNA) delivery technologies for the...