Head Clinical Development Operations

The Head of Clinical Development Operations will be involved in all aspects of management of clinical development. The position reports to the Chief Medical Officer. Roles and responsibilities include the following:

Supervise all aspects of clinical development involved in phases I-IV and data collection.
Oversees the activities of the clinical project managers and their supporting staff, including CRAs, monitors, and others, in the Clinical Operations group.
Ensures that Clinical plans are appropriate and implemented with quality, speed and value.
While not the primary individual responsible for the clinical development strategy, this role is expected to make a major contribution to defining and evaluating that strategy and assessing the logistic opportunities of the proposed and competing strategies.
Coordinates clinical operations, including investigative site management and monitoring activities.
A key deliverable of this role is developing an organization capable of working "virtually" i.e. making optimum use of contract resources and networks.
Coordinates the review, selection and management of vendors, contractors, contract monitors, and other outsourcing options to support project goals.
Works with the Medical Directors in ensuring clinical trials are conducted and reported in accordance with ICH GCPs, applicable regulations, and relevant Vanda Pharmaceuticals SOPs.
Coordinates writing, review, and implementation of Clinical SOPs
Assists with review and forecast of department workload, staffing, and resource allocation, as well as management of Clinical staff.
Ensures that Clinical staff is adequately trained and oriented.
Identifies areas of professional development for CRAs, coordinates educational sessions and speaker topics for Department.
REQUIREMENTS
Eight (8) or more years of relevant experience including demonstrated laboratory experience including experience in the administrative process related to USP-NF programs. Established skills in written and oral communication.