Job Code:
Location:
West Coast
Job Summary
Works closely with matrix team leaders in advancing early product candidates, with a focus on maximizing information from clinical trials through the application of advanced imaging technologies. Leads and manages colleagues in coordinating approaches to scientific/operational issues of clinical trials. Provides guidance and assistance in the identification and management of phase one units, relevant external collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects. Possesses a thorough understanding of the science behind projects. Ensures efficiencies and enhancements of data collection, analysis, and study report processes. With the assistance of support staff, monitors the status of clinical trials and assists in resolving major issues that may affect studies. Provides quality control oversight to ensure that quality standards in trial conduct are maintained.
Determines resource capacity strategy to fulfill early product development imaging needs. Defines current and future operational demands and utilizes expertise of resource flexibility for change in demands. Reviews and provides critical input to departmental and project budgets, contracts and policies. Corresponds with development operations in resource capacity needs and planning. Ensures that appropriate training, recruitment, and development requirements for matrix team resources are accomplished. Promotes values and standards.
Establishes optimum communication and coordination of informational channels within the company, including functional area updates, library and resource services, and space allocations.
Represents Imaging Sciences within a number of internal functional groups and task forces. Enables the use of advanced imaging technologies across therapeutics at all stage of development. Shares best practices with other therapeutic area leaders. Promotes understanding of Imaging Sciences both internally and externally.
Basic Qualifications:
M.D., Ph.D., or Pharm D., postgraduate clinical residency and research fellowship training in advanced imaging technologies.
The successful candidate must have at least 10 years of experience in the academic and/or pharmaceutical/biotechnology company arena, including 5 years of supervisory/management experience. 5 years of experience in early phase clinical trials is required.
Competencies/Skills:
Knowledge of regulatory requirements regarding clinical trial conduct with a focus on advanced imaging technologies. Ability to effectively present ideas and to document activities in both written and oral communication. Demonstrated ability and experience functioning in a complex matrix environment. In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale. Ability to effectively anticipate problems and find creative solutions. Able to be both proactive and responsive to issues. History of solving problems while exhibiting exceptional judgment and a balanced, realistic understanding of issues.