The Executive Director, Clinical Research Physician manages and supervises the clinical, scientific, administrative, and technical activities for the Leukemia area, required to conceive, and execute clinical studies within the department with emphasis on overall clinical study leadership. This work is carried out at the direction of senior management in line with departmental strategic goals. This person also ensures quality, timely and coordinated clinical study activities within the Corporation
and ensures compliance with the appropriate GCP/ICH and health authority guidelines. This individual provides clinical development expertise on behalf of the company and represents the Corporation at appropriate academic centers, medical and regulatory meetings.
The Clinical Research Physician also is responsible for assisting senior management, in establishing and achieving long-term Corporate Strategic goals and tactical objectives.
Specific Duties (Include, But Are Not Limited To):
1. Provides leadership to the clinical study team involved in the execution of clinical studies.
2. Oversees and is responsible for the quality, coordination and timeliness of protocol development.
3. Oversees and is responsible for the quality, coordination, medical accuracy and timeliness of clinical study reports.
4. Assists senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISSís, ISEís, and clinical expert reports.
5. Participates, as required, as a clinical representative on Project Teams.
6. Establishes and maintains working relationship with Study investigators, key opinion leaders, academicians, and Celgene Senior managers and department heads across the corporation.
7. Ensures adherence to GCP/ICH and Celgene SOP standards.
8. Maintains clinical and scientific awareness in area of expertise.
9. Supports clinical operations in site selection, study budget preparation, study execution and addresses clinical/medical issues at study sites.
10. Participates in the organization, coordination and execution, as required, of internal meetings and external medical/scientific meetings, e.g., Investigator Meetings and clinical/scientific advisory board meetings.
11. Develops and gives oral presentations, as required.
12. Supports data management as required for CRF development, database edit checks development, listings review, query resolution, database clean-up and lock activities.
13. Prepares clinical study timelines and status reports, as required, per Supervisor.
An advanced degree in a relevant field (MD) with experience in clinical research and development. 5-10 years clinical drug development process experience preferred.
Knowledge of and strict adherence to GCP/ICH guidelines and internal SOPs in Clinical Research and Development.
Excellent managerial and leadership skills or clear potential to develop such skills.
Excellent verbal communication skills to effectively represent the company at a corporate level, with internal working groups/project teams and external academic/industrial/regulatory organizations.
· Excellent technical writing written skills.
· Team player, possesses sense of urgency, and exhibits potential for mentoring others.
Must have planning skills to schedule activities to meet Clinical Research and Development and project team deadlines. The position requires problem solving ability, and skills to address medical, clinical study and technical questions in a multi-disciplinary environment. Must be technically proficient with standard PC software (Word, Excel, PowerPoint, Desktop products like Outlook). Must keep abreast of medical and scientific literature within the relevant therapeutic area that the individual is working in. Must maintain high ethical standards and integrity at all times.