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Job Title: Clinical Research Physician - NJ--Large Global Pharma
Contract position – 8 months contractor and have a high chance to extend
Location: Summit, NJ
The Clinical Research Physician manages and supervises the clinical, scientific, administrative, and technical activities 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 Celgene 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 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, ISS's, ISE's, 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. Supports clinical operations in site selection, study budget preparation, study execution and addresses clinical/medical issues at study sites.
9 Participates in the organization, coordination and execution, as required, of internal Celgene meetings and external medical/scientific meetings, e.g., Investigator Meetings and clinical/scientific advisory board meetings.
10. Develops and gives oral presentations, as required.
11. Supports data management as required for CRF development, database edit checks development, listings review, query resolution, database clean-up and lock activities.
12. Prepares clinical study timelines and status reports, as required, per Supervisor.
The position requires an individual with:
An advanced degree in a relevant field (MD, Ph.D., Pharm.D or equivalent advanced degree, with experience in clinical research and development. 2-5 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 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, is mentorable 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.
SUPERVISION: DIRECT and INDIRECT:
Supervises internal Clinical Research and Development staff as required. Also interfaces with CRO's, academics, and external experts as appropriate.
This position has responsibility, for the quality, timeliness, and medical/scientific acceptability of protocols, clinical study execution, and medical accuracy and timeliness of clinical study reports. This position has cross-functional accountability to the clinical study team and project team, as required. This position must ensure GCP/ICH compliance.
INTERNAL: Frequent contact with various levels of R&D as well as moderate contact with colleagues in other departments (regulatory, drug safety, project management, toxicology, drug discovery, marketing, finance, business development, etc
EXTERNAL: Moderate contact with CRO's, academicians, regulatory agencies, external experts and appropriate professional groups
Domestic and international travel has been removed as a requirment of this job. There won't be any travel.
For therapeutic area Mgr prefers rheumatology but Inflammation and immunology would also suffice