[Hiring] Medical Director, Oncology @IQVIA

Role Description

The Medical Director provides medical and scientific support to clinical research programs, study teams, and investigators. The primary role 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.

• 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.
• 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.
• Participates in subject recruitment and retention activities.
• Presents protocol and/or safety reporting information at investigator meetings.
• Develops project medical monitoring plans as requested.
• Assists the team and sites in responding to protocol-related or study-related or medical questions.
• Provides on-call coverage for protocol queries and site support.
• Provides first line contact for investigators and monitors regarding study-related medical/safety 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.
• 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, updates to Investigator Brochures, and annual IND reports with sponsor data.
• In consultation with the sponsor, follows procedures for acquiring knowledge of subject treatment assignments.
• Interacts with appropriate FDA officials concerning safety and other study-related issues, as requested.

Data Activities:

• Provides medical review of eCRFs for clinical accuracy.
• Provides medical review of data analysis plan.
• Reviews safety fields at case freeze for reconciliation.
• 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.

Qualifications

• Medical Degree from an accredited and internationally recognized medical school.
• Board Certified / Board Eligible: Oncology.
• 10 years of experience is required, which can include medical practice, academia, clinical research, or drug development.
• 3-5 years of biopharmaceutical (industry) experience is preferred.
• Ability to work in partnership with a multidisciplinary group of colleagues.
• Outstanding ability to work independently with minimal supervision.
• Ability to organize and work efficiently on several projects with specific requirements.
• Excellent oral and written communications skills as well as interpersonal skills.

Company Description

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.