IQVIA Senior Medical Director, Biopharma (Home-Based) - Novella Clinical in Missouri
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 Novella 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 JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Functions as project team member
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
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 FDA officials concerning safety and other study related issues, as requested
Provides medical review of eCRFs for clinical accuracy
Provides medical review of data analysis plan
Reviews safety fields at case freeze for reconciliation (if needed)
Works with data group to reconcile SAE events as needed
Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends
Reviews data tables, listings, and figures
Reviews and/or writes portions of final clinical study report
DSMB/Adjudication Committee Activities:
Assists sponsor in choosing committee members
Serves as a non-voting member to convene and organize proceedings
Develops operating guidelines in conjunction with committee members and submits these to sponsor for review
Determines data flow with sponsor to ensure reporting accuracy
Ensures DSMB feedback is given to sites for IRBs
Business Development Activities
Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development
Supports business development activities with proposal development and sales presentations
Participates in feasibility discussions relating to specific project proposals
Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities
Participate in a variety of team quality improvement efforts as necessary
Perform other related duties as assigned or requested by the Chief Medical Officer
Licensed M.D.; board certification/eligibility ideal
Minimum 3-5 years of biopharmaceutical industry experience or academic experience in clinical research and drug development
EEO Minorities/Females/Protected Veterans/Disabled
USA-Delaware, USA-New Jersey, USA-Missouri, USA-Illinois, USA-Ohio, USA-Tennessee, USA-Pennsylvania, USA-Indiana, USA-Michigan, USA-Virginia, USA-New York, USA-Massachusetts, USA-Florida, USA-Connecticut