Global Development Senior Medical Director, Hematology Oncology
HybridWarsaw, Mazovia, Poland
EXPIREDWarsaw, Mazovia, PolandHybridFull TimeSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
Lead clinical development for hematology oncology programs by designing and implementing global trial strategies, managing protocol governance, and ensuring regulatory compliance with FDA, EMA, and ICH guidelines. Serve as Medical Monitor for Phase I/II and III studies, overseeing safety data review, protocol interpretation, and the delivery of clinical study reports. Drive program strategy from discovery through late-stage development, collaborating with cross-functional teams to advance assets and manage lifecycle programs.
Required Qualifications
- MD or international equivalent
- Medical hemato-oncology clinical training
- Minimum of 4 years of relevant experience
- Board Certification
- Significant clinical research experience (in industry, academic or CRO environment) related to drug development, design and/or conduct of clinical studies in oncology and/or malignant hematology
- Detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research
- General knowledge of 1) medical monitoring; 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals
- Demonstrated ability to both independently complete, and lead peers in completion in components of complex plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools
- Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally
- Minimum of 3 days per week in the office
- Location in Warsaw, Poland, Boston, Massachusetts, South San Francisco, California, Gaithersburg, United States, or Barcelona
Desired Qualifications
- Board Certification
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