Description
The Medical Director provides medical and scientific support to clinical research programs, study teams, and investigators. The role involves providing medical oversight for clinical trials, serving as a Medical Monitor for studies, and being the primary contact for sponsor medical teams.
Essential Functions The Medical Director will:
- Provide medical and scientific input to clinical research programs, including reviewing new business proposals, study protocols, and clinical study reports
- Ensure medical activities run according to GCP and operate with highest efficiency
- Establish and maintain a network of medical/scientific consultants
- Supervise and manage Medical Director activities
Clinical Activities The Medical Director will:
- Interact with clients regarding drug development programs, study design, and protocol
- Review and provide input for protocol development
- Develop project medical monitoring plans as requested
- Provide on-call coverage for protocol queries and site support
Safety Monitoring and SAE Reporting Activities The Medical Director will:
- Verify the medical accuracy of patient safety data and maintain an ongoing assessment of the safety profile of the study
- Provide medical review of SAE reporting, write and/or review SAE narratives, and work with the Safety Management Department to track SAEs
Data Activities The Medical Director will:
- Provide medical review of eCRFs for clinical accuracy
- Review safety fields at case freeze for reconciliation (if needed)
- Review medical coding of adverse events, laboratory data, and concomitant medications for accuracy, coherence, consistency, and trends
DSMB/Adjudication Committee Activities The Medical Director may:
- Assist the sponsor in choosing committee members
- Serve as a non-voting member to convene and organize proceedings
- Develop operating guidelines in conjunction with committee members
Business Development Activities The Medical Director will:
- Work with Business Development to actively solicit new business for Novella Clinical
- Support business development activities with proposal development and sales presentations
Special Projects The Medical Director will:
- Obtain literature searches to acquire background information for study proposals
- Assist with drafting of standard operating procedures and working practices regarding all Medical Director activities
Qualifications The Medical Director should have:
- A Medical Degree from an accredited and internationally recognized medical school
- 10 years of experience, including medical practice, academia, clinical research, or drug development
- 3-5 years of biopharmaceutical industry experience (preferred)
- Board certification in Oncology (required)
- Excellent oral and written communication skills, as well as interpersonal skills