Global Development Medical Director, Hematology Oncology
HybridWarsaw, Mazovia, Poland
Job Summary
Lead clinical development and medical monitoring for hematology oncology programs, driving design, implementation, and closure of early and late-phase trials. Provide expert input to study sites, primary investigators, and regulatory agencies on protocol development, safety, and compliance with GCP and FDA/EMA guidelines. Present clinical data, defend protocols at governance forums, and prepare regulatory submissions including INDs, BLAs, and annual safety reports. Manage risk-benefit assessments and ensure scientific rigor across the value chain from discovery to registration. Collaborate cross-functionally with medical affairs, operations, and commercial teams to align clinical strategies with business objectives and accelerate life-changing medicines.
Required Qualifications
- MD or international equivalent
- Minimum of 2 years of relevant experience
- Medical hemato-oncology clinical training
- Board Certification
- General knowledge of Good Clinical Practice (GCP)
- General knowledge of other regulations governing clinical research
- General knowledge of medical monitoring
- General knowledge of regulatory approval process in relevant countries
- General knowledge of pharmaceutical industry/R&D operations
- General knowledge of marketing and commercial fundamentals
- Good understanding of clinical trials methodology
- Strong communication & presentation skills
Desired Qualifications
- Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or malignant hematology
- Possesses general knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research
- Possesses general knowledge of 1) medical monitoring; 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals
- Good understanding of clinical trials methodology
- Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally
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