Director, Clinical Trial Management
Other Locations:US- CA- San Diego- Science Park
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Position is located in San Diego on Science Park Rd.
The Director, Clinical Operations, is to coordinate, manage and supervise operational activities associated with clinical development programs, including: maintenance of essential study documentation, dissemination of key information to clinical advisors, CROs and ancillary vendor partners and participating investigators; establishing and managing contracts and budgets with clinical investigators and clinical trial service providers; preparing clinical trial documents (e.g., protocols, investigators brochures, site operations manuals) and; ensuring that these activities are conducted in accordance with all applicable regulations, and ICH and GCP guidance standards. In addition, this individual will ensure preparation of departmental standard operating procedures, working procedures and templates, and is also responsible for tracking and reporting budgets and timelines for clinical programs.
Experience with late stage global clinical development required. NDA filing and therapeutic experience with auto-immune mediated diseases highly desired.
- Evaluate potential contract research organizations (CROs), vendors and other service providers for use in Celgene clinical studies.
- Ensure qualification of CROs, vendors and service providers in accordance with Celgene SOPs.
- Manage vendors and/or personnel providing the operational functions of Celgene clinical programs. Participate in functional guidance, training, education and evaluation of vendors and/or personnel.
- Supervise and ensure Celgene oversight of the activities of internal staff, CROs, contractors and other vendors as they are related to the clinical programs, in accordance with relevant plans and scope of work.
- Ensure screening and evaluation of potential Investigators to ensure compliance with regulatory and corporate requirements.
- Supervise negotiation of Investigator agreements and grants appropriate to the clinical programs.
- Ensure review and approval of written reports of all site monitoring visits prepared by CRAs to ensure they are completed in a timely fashion and according to Federal regulations, GCP and Celgene SOPs.
- Ensure maintenance of essential documents associated with Celgene clinical trials, in accordance with applicable regulations and international guidance's.
- Participate in corporate committees, task forces, technical or business meetings as requested.
- Ensure timely and appropriate response to clinical investigator site issues or other study management problems. Ensure maintenance of documentation in appropriate reports of all communications, particularly those in which patient or protocol issues are discussed.
- Prepare and/or assist in the preparation of communication and status reports to provide updates/information to executive management.
- Direct clinical operations activities in preparation of interim analyses, clinical study reports, annual reports and other clinical documents.
- Demonstrate mastery of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials.
- Assist in the development and maintenance of departmental standard operating procedures (SOPs) in collaboration with other functional groups and under the direction of Quality Assurance.
- Represent Celgene in a professional manner; establish and maintain good relationships with Investigators, advisors, other study personnel, clients and vendors.
- Attend seminars, Investigator meetings, project team meetings, educational conferences/training sessions, etc.
- Other responsibilities as assigned.
Knowledge, Skills and Abilities Required:
- Bachelor's Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study.
- Minimum of 10 years of experience in prior positions of increasing responsibility in clinical operations, and a proven track record of successful management of clinical research and support personnel, departmental budgets and timelines in the pharmaceutical/biotech industry.
- Knowledge of medical terminology required.
- Computer literacy (Word/Excel), familiarity with clinical database concepts, and experience with statistical principles is required.
- Position may require travel expected to be no more than 20% (domestic and international).