Senior Medical Director, Hematology/Oncology

The medical department consists of a Chief Medical Officer, Medical Directors, medical writers, and safety associates.  The Senior Medical Director provides medical and scientific support to clinical research programs, study teams and investigators.  The Senior Medical Director also provides review, advice, and leadership for potentially or actually awarded clinical research programs.

The Senior Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams.  The primary role of Senior Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference.

Essential Functions

·       Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting

·       Ensures medical activities run according to GCP and operate with highest efficiency

·       Establishes and maintains a network of medical/scientific consultants, etc.

·       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.  Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints.  Interacts in team approach to develop statistical and data management sections of the protocol.  Reviews the final protocol for clinical, safety and efficacy variables.

·       Provides project team training on protocol and/or therapeutic areas

·       Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation.  Aids in review and final selection.

·       Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentations

·       Presents protocol and/or safety reporting information at investigator meetings

·       Develops project medical monitoring plans as requested

·       Provides on call coverage for protocol queries and site support.  Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.

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, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed  

·       Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data

·       In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)

·       Interact with appropriate