Senior Medical Director, Oncology/Hematology

10+ years

$186,300.00 - $519,000.00

Durham

10 Oct. 4, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🏷️ Job Title: Senior Medical Director, Oncology/Hematology

📍 Location: Durham, North Carolina
🕒 Employment Type: Full Time
🔢 Job ID: R1504137
🏢 Work Type: Home-based
📍 Additional Locations: North Carolina

🧭 Position Overview

The Senior Medical Director (SMD) provides medical oversight for clinical trials conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The SMD serves as Medical Monitor, acting as the primary medical contact for sponsors, investigative sites, and project teams. This role ensures protocol compliance, patient safety, and accurate data reporting across all study activities.

⚙️ Key Responsibilities

Project Team Participation

Function as an active member of the project team.
Provide medical and scientific input for clinical programs, including:
- Review of proposals, preclinical/clinical data, protocols, training materials, informed consent, Investigator Drug Brochures (IDB), eCRFs, analysis plans, CSRs, and regulatory submissions.
Ensure medical activities comply with GCP and are conducted efficiently.
Establish and maintain a network of medical/scientific consultants.
Supervise and manage activities of other Medical Directors.

Clinical Activities

Interact with clients regarding drug development programs, study design, and protocols.
Provide input on protocol development, including inclusion/exclusion criteria, endpoints, and statistical/data management sections.
Conduct protocol and therapeutic area training for project teams.
Support investigator site selection and recruitment activities.
Present protocol/safety information at investigator meetings.
Develop project medical monitoring plans.
Provide 24/7 on-call coverage for protocol queries and site support.

Safety Monitoring & SAE Reporting

Verify medical accuracy of patient safety data.
Review SAE reports and narratives, collaborating with Safety Management.
Update Investigator Brochures, IND/SUSAR Safety Reports, and annual IND reports.
Follow procedures for acquiring knowledge of subject treatment assignments when needed.
Interact with FDA officials on safety and study-related matters.

Data Management

Review eCRFs for clinical accuracy.
Review data analysis plans, adverse event coding, lab data, concomitant medications, and data tables/listings/figures.
Contribute to Clinical Study Report (CSR) preparation.

DSMB / Adjudication Committee Support

Assist sponsors in committee member selection.
Serve as a non-voting member to convene and organize proceedings.
Develop operating guidelines and ensure accurate reporting to sponsors.
Facilitate DSMB feedback to sites when required.

Business Development

Support marketing presentations, proposal development, and sales activities.
Participate in feasibility discussions for project proposals.

Special Projects

Conduct literature searches and data interpretation.
Draft SOPs related to Medical Director activities.
Participate in quality improvement initiatives.

🎓 Qualifications

Education: Current or prior license to practice medicine.
Experience:
- Minimum 10 years in biopharmaceutical industry or academic clinical research.
- Clinical trials experience in Pharma, CRO, or Biotech.
Certification: Board certification or eligibility in Hematology/Oncology preferred.
Skills & Abilities:
- Ability to work independently and in a matrix team environment.
- Strong organizational skills to manage multiple projects with shifting priorities.
- Excellent oral, written, and interpersonal communication skills.
- Ability to translate concepts into practical approaches and achieve consensus.

🌍 About IQVIA

IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence, connecting data, technology, and expertise to accelerate the development and commercialization of innovative medical treatments.

🔗 Learn more: https://jobs.iqvia.com

⚖️ Equal Employment Opportunity

IQVIA provides equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

💰 Compensation

Base Pay Range (Annualized): $186,300 – $519,000
Additional incentives, bonuses, and benefits may apply.

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Senior Medical Director, Oncology/Hematology

Job Description

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