Description
The Medical Director provides medical and scientific support to clinical research programs, study teams, and investigators. The role involves serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies.
Essential Functions
- Provides medical and scientific input to clinical research programs, including review of new business proposals, preclinical and/or clinical data, study protocols, and clinical study reports.
- Ensures medical activities run according to GCP and operate with highest efficiency.
- Establishes and maintains a network of medical/scientific consultants.
- Supervises and manages Medical Director activities.
Clinical Activities
- Interacts with clients regarding drug development programs, study design, and protocol.
- Reviews and provides input for protocol development.
- Develops project medical monitoring plans as requested.
- Provides on-call coverage for protocol queries and site support.
Safety Monitoring and SAE Reporting Activities
- Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study.
- Provides medical review of SAE reporting, writes and/or reviews SAE narratives.
- Reviews IND/SUSAR Safety Reports, updates to Investigator Brochures, and annual IND reports with sponsor data.
Data Activities
- Provides medical review of eCRFs for clinical accuracy.
- Reviews safety fields at case freeze for reconciliation.
- Works with data group to reconcile SAE events as needed.
DSMB/Adjudication Committee Activities
- May assist sponsor in choosing committee members.
- May serve as a non-voting member to convene and organize proceedings.
Business Development Activities
- Works with Business Development to actively solicit new business for Novella Clinical.
- Supports business development activities with proposal development and sales presentations.
Special Projects
- Obtains literature searches to acquire background information for study proposals.
- Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities.
Qualifications
- 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 Certified/Board Eligible: Oncology.
- Excellent oral and written communications skills, as well as interpersonal skills.