Job Title:
Senior Medical Director – Oncology/Hematology
Location:
Primary: Durham, North Carolina (Home-Based)
Additional: North Carolina
Employment Type:
Full-Time
Job ID:
R1504137
Company Overview:
IQVIA is a global leader in clinical research services, healthcare analytics, and life sciences innovation. We connect data, technology, and expertise to accelerate the development and commercialization of medical breakthroughs, ultimately improving patient outcomes and public health.
🔗 Learn more: https://jobs.iqvia.com
Job Overview:
The Senior Medical Director provides medical oversight and strategic leadership for oncology and hematology clinical trials conducted by IQVIA Biotech Clinical.
This role functions as a Medical Monitor and key liaison between sponsor medical teams and internal project teams—ensuring clinical excellence, patient safety, and regulatory compliance.
The position requires 24/7 availability for urgent medical queries (per sponsor requirements).
Key Responsibilities:
1. Core Medical & Clinical Functions
Serve as Medical Monitor and primary contact for sponsor medical teams.
Provide medical and scientific input to all stages of clinical development.
Review and approve:
Study protocols
Investigator Brochures
Informed consent forms
Case Report Forms (CRFs)
Data analysis plans and clinical study reports
Ensure all activities comply with GCP and internal quality standards.
Supervise and mentor Medical Directors within the team.
2. Clinical Oversight
Advise on study design, inclusion/exclusion criteria, and endpoints.
Collaborate with statisticians, data managers, and clinical operations for protocol optimization.
Conduct training sessions for project teams and investigators.
Support investigator site selection and recruitment strategies.
Participate in investigator meetings, teleconferences, and WebEx sessions.
Develop and implement Medical Monitoring Plans (MMPs).
Provide on-call coverage for protocol and safety-related queries.
3. Safety Monitoring & Pharmacovigilance
Continuously assess the safety profile of ongoing trials.
Review and verify Serious Adverse Events (SAEs) for accuracy.
Write/review SAE narratives and collaborate with the Safety Management Department.
Evaluate SUSARs, IND reports, and Investigator Brochure updates.
Participate in safety discussions with FDA or other regulatory authorities as needed.
Maintain full compliance with sponsor-specific unblinding and reporting procedures.
4. Data Management & Quality Review
Review eCRFs, medical coding, and laboratory data for clinical consistency.
Collaborate with data teams on SAE reconciliation and data freeze reviews.
Assess adverse event trends and ensure coding accuracy.
Review tables, listings, and figures (TLFs) prior to CSR finalization.
Contribute to or author sections of the Clinical Study Report (CSR).
5. DSMB & Adjudication Committee Activities
Assist sponsors in selecting DSMB or adjudication committee members.
Support development of operating guidelines and data review procedures.
Ensure accurate data flow and feedback reporting to IRBs.
(Note: DSMB activities typically managed by the IQVIA Biotech Oversight Management Group.)
6. Business Development
Collaborate with Business Development teams to attract and secure new clients.
Support proposal development, feasibility assessments, and sales presentations.
Provide scientific input during bid defense and client negotiations.
7. Special Projects & Quality Initiatives
Conduct literature reviews and background research for study proposals.
Assist in drafting and refining Standard Operating Procedures (SOPs).
Participate in process improvement and quality enhancement initiatives.
Perform additional duties as assigned by the Chief Medical Officer (CMO).
Qualifications:
Education:
MD or equivalent medical degree from an accredited institution.
Board Certification (or eligibility) in Hematology/Oncology preferred.
Current or prior license to practice medicine required.
Experience:
Minimum 10 years in biopharmaceutical, academic, or clinical research settings.
Proven expertise in clinical research and drug development.
Strong leadership in oncology/hematology clinical trial oversight.
Experience managing teams and collaborating in a matrix environment.
Skills:
Exceptional written and oral communication skills.
Strategic thinking with high clinical and scientific acumen.
Ability to manage multiple complex projects simultaneously.
Strong interpersonal and cross-functional collaboration skills.
Compensation:
💰 Annual Base Pay Range: $186,300 – $519,000
(Actual pay determined by experience, qualifications, and location.)
Additional compensation may include:
Incentive plans
Bonuses
Comprehensive health and welfare benefits
Retirement savings plans
Equal Employment Opportunity (EEO):
IQVIA is an equal opportunity employer. All qualified applicants will receive consideration without regard to:
Race
Color
Religion
Sex
Sexual orientation
Gender identity
National origin
Disability
Protected veteran status
🔗 EEO Policy: https://jobs.iqvia.com/eoe
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