Position: Senior Medical Director, Oncology/Hematology
📍 Location: Durham, North Carolina (Home-based)
🕒 Employment Type: Full-Time
💼 Job ID: R1504137
🌐 Additional Locations: North Carolina
About IQVIA
IQVIA is a global provider of clinical research services, commercial insights, and healthcare intelligence. We accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health.
🔗 Learn more: https://jobs.iqvia.com
Position Overview
The Senior Medical Director provides medical oversight for clinical trials, acting as Medical Monitor for studies conducted on behalf of sponsor companies. The role serves as the primary medical contact for sponsors and project teams, ensuring clinical and safety guidance throughout the trial lifecycle.
The Medical Monitor is available 24/7 to answer protocol-related queries from sites, including eligibility, safety, and compliance issues, and review alert labs as per sponsor requirements.
Key Responsibilities
Project Team Functions
Participate as a project team member within a matrix reporting structure.
Provide medical and scientific input for clinical research programs, including:
Review of business proposals, preclinical/clinical data, study protocols, training materials, informed consent forms (ICFs), Investigator Drug Brochures (IDBs), eCRFs, analysis plans, CSRs, and regulatory submissions.
Supervise and manage activities of Medical Directors as required.
Establish and maintain a network of medical/scientific consultants.
Clinical Activities
Review and provide input on protocol development, inclusion/exclusion criteria, and study endpoints.
Conduct project team training on protocols and therapeutic areas.
Assist in investigator site selection and networking for study participation.
Participate in subject recruitment and retention activities.
Present protocol and safety information at Investigator Meetings.
Develop medical monitoring plans.
Provide on-call coverage for protocol queries and site support regarding patient safety, protocol, and eligibility issues.
Safety Monitoring & SAE Reporting
Ensure accuracy of patient safety data and maintain ongoing safety assessments.
Review and write SAE narratives, track follow-up actions, and interact with sponsors.
Review IND/SUSAR Safety Reports, updates to IDBs, and annual IND reports.
Follow procedures for unblinding as required.
Interact with FDA officials regarding safety and study-related issues as needed.
Data Activities
Review eCRFs, data analysis plans, and safety fields at case freeze.
Reconcile SAE events with the data group.
Review adverse event coding, laboratory data, concomitant medications, and data tables/listings/figures.
Contribute to final clinical study reports.
DSMB / Adjudication Committee Support
Assist sponsor in selecting committee members and serve as non-voting member.
Develop operating guidelines and ensure accurate data flow and feedback to sites.
Activities usually coordinated with IQVIA Biotech Oversight Management Group.
Business Development
Support marketing presentations, proposal development, and feasibility discussions.
Actively solicit new business opportunities.
Special Projects
Conduct literature searches and prepare training sessions.
Draft SOPs related to Medical Director activities.
Participate in quality improvement initiatives and other related duties as assigned.
Qualifications
Education & Certification
Medical license (current or prior) to practice medicine.
Board certification/eligibility in Hematology/Oncology preferred.
Experience
Minimum 10 years of biopharmaceutical or academic clinical research experience.
Proven ability to work independently and in a matrix team environment.
Experience managing multiple projects with shifting priorities.
Skills & Competencies
Strong clinical, medical, and regulatory knowledge in Hematology/Oncology.
Ability to translate concepts into practical approaches and build consensus.
Excellent oral, written, and interpersonal communication skills.
Strong organizational and multitasking skills.
Compensation & Benefits
Base pay range: $186,300 – $519,000 per year (annualized)
Actual pay may vary based on experience, qualifications, location, and schedule.
Incentives, bonuses, and a range of health and welfare benefits may also be offered.
Equal Opportunity Employer
IQVIA considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected status.
📩 Apply Now: IQVIA Careers – Senior Medical Director
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