Medical Director of Hematology (Remote – USA)
Job ID: REQ-10064088
Posted on: November 14, 2025
Location: United States (Remote)
Company: Novartis Pharmaceuticals Corporation
Employment Type: Full-Time | Regular
Functional Area: Research & Development
Role Overview
Novartis is seeking an experienced Medical Director of Hematology to lead strategic and operational Global Medical Affairs programs. This role focuses on evidence generation, launch readiness, and post-market medical initiatives supporting patient outcomes, clinical value, and healthcare system impact. The Medical Director will contribute to Integrated Evidence Plans (IEP), guide end-to-end program execution, and drive medical/scientific engagement for key hematology indications.
This position offers the opportunity to lead US Medical Affairs and Global Clinical Development activities, collaborate across cross-functional teams, and shape clinical and medical strategies supporting the launch portfolio.
Key Responsibilities
Clinical Development & Medical Affairs Leadership
Serve as US Medical Director for multiple Phase I–IV clinical development programs, US Medical Affairs trials, Expanded Access programs, registries, and Investigator-Initiated Trials (IITs).
Lead the design, development, and optimization of clinical trial protocols aligned with indication strategy.
Review and interpret efficacy and safety data, ensuring regulatory and ethical compliance.
Regulatory & Documentation Excellence
Oversee quality and medical accuracy of clinical study reports, IND clinical sections, CTAs, Investigator Brochures, ISS/ISE documents, expert reports, and label review.
Provide US medical input into Global Development Plans and Global Protocols.
Author clinical sections for regulatory submissions and respond to health authority inquiries.
Medical Affairs Strategy & Execution
Develop and implement US Medical Affairs strategy, including exploratory indications and integration into broader global plans.
Oversee IIT concept review and ensure appropriate safety monitoring during trial conduct.
Review interim and final publications, abstracts, manuscripts, and clinical presentations.
Cross-Functional & External Collaboration
Lead US disease area clinical teams and collaborate with Safety, HEOR, Medical Information, Scientific Communications, Commercial, Regulatory, and Research.
Work closely with academic investigators and external medical experts to optimize trial strategies and scientific engagement.
Support and participate in FDA meetings, including preparation of briefing materials.
Operational Excellence
Ensure adherence to GCP, ICH guidelines, and company SOPs.
Support clinical budget planning and ensure efficient resource utilization.
May supervise and mentor team members within the US medical team.
Position Requirements
Education
MD, PhD, PharmD, or equivalent required.
For MD candidates: Board Certified or Board Eligible in Hematology, Oncology, or relevant medical specialty.
Experience (Required)
Minimum 3–10 years of experience in Hematology/Oncology clinical research within the pharmaceutical industry, academic medicine, or combined experience in clinical development/medical affairs.
Demonstrated expertise in Oncology and/or Hematology with a strong publication record.
Proven experience leading the design, execution, and reporting of clinical studies.
Core Competencies
Strong scientific and clinical understanding of hematologic diseases.
Excellent leadership, networking, and cross-functional collaboration skills.
Effective verbal and written communication abilities.
Demonstrated capability in strategic planning and operational execution across multi-center research programs.
Successful engagement with medical experts, investigators, and regulatory stakeholders.
Position level will be determined based on experience and qualifications.
Why Join Novartis
Helping people living with serious diseases requires scientific excellence and a passionate community. Novartis offers an opportunity to collaborate, innovate, and contribute to breakthroughs that transform patients' lives. Learn more about our culture and people strategy on the Novartis People and Culture page.
Additional Information
Equal Employment Opportunity
Novartis is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any legally protected characteristic.
Accessibility & Accommodations
Candidates requiring reasonable accommodation during the application or interview process may contact:
us.reasonableaccommodations@novartis.com
Please include the job requisition number in your request.
Business Unit: US Marketing
Shift Work: No
Work Type: Remote (USA)
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