Role Summary
Clinical Trial Physician, Hematology. The role sits within Clinical Development and involves design, execution, and interpretation of clinical trials in hematology-related programs, collaborating with cross-functional teams to advance drug development and regulatory strategy.
Responsibilities
- Contributes to and is a key member of a high performing Study Delivery Team (SDT) and of the Clinical Development Team (CDT).
- Designs and develops clinical plans and protocols with a strategic focus based on asset, disease area, and relevant science to meet regulatory and disease strategy targets; leads benefit/risk analysis for protocols in a matrix environment with Clinical Scientists.
- Conducts medical data review of trial data, including eligibility review.
- Handles site interactions for medical questions and education (including safety management guidelines).
- Assesses key safety-related serious adverse events in partnership with GPVE and oversees safety narratives.
- Fulfills GCP and compliance obligations for clinical conduct and maintains required training.
- Collaborates with Clinical Scientists on protocols, providing medical oversight in protocol development and signs off on protocols.
- Identifies and builds relationships with principal investigators and thought leaders to gain inputs on emerging science and study design.
- Maintains strong medical/scientific reputation in the disease area; stays current with etiologies, natural history, diagnosis, and treatment; attends scientific conferences and reviews literature.
- Keeps abreast of development and regulatory issues related to other compounds and how the portfolio fits into the competitive landscape.
- Provides ongoing medical education and protocol-specific training to support study teams and investigators.
- Contributes to Health Authority interactions and advisory board meetings; drafts clinical content for CSRs, regulatory reports, briefing books, and submission documents in collaboration with Clinical Scientists.
- Reports to Clinical Development Lead (CDL) and gains broad experience in matrix team management and development planning.
Qualifications
- MD required (or international equivalent) with a Clinical Trial Physician assignment.
- 3+ years of industry experience with clinical trials.
- Subspecialty training in oncology and/or hematology or applicable therapeutic area (preferred).
- Expertise in scientific method, including statistical design, analysis, and interpretation.
- Knowledge of the drug development process and components of an effective clinical plan and protocols.
- Strong leadership skills and ability to lead and work effectively in a team environment.
Skills
- Medical and scientific expertise in hematology/oncology and drug development.
- Ability to manage cross-functional, matrix-driven projects across internal and external networks.
- Proficiency in presenting scientific and clinical information clearly.
Education
- Medical Doctor (MD) or equivalent; subspecialty training in oncology/hematology or relevant field (preferred).