Principal Clinical Scientist, Clinical Development - Hematology
Core
Lead scientific development and execution of clinical programs in the Hematology therapeutic area, ensuring patient safety, data integrity, and regulatory compliance.
Role type
Principal Clinical Scientist (Clinical Development)
Builds
Clinical development programs, study protocols, regulatory submission documents, and scientific publications for hematology therapies.
Domain
Biotechnology/Pharmaceuticals, Hematology, Clinical Development
Required skills
Drug development lifecycle knowledge (CMC, non-clinical, clinical, Regulatory Affairs), Clinical research management, CRO oversight, Scientific data analysis and interpretation, Regulatory document authorship, Cross-functional collaboration
Preferred skills
PMP Certification, Advanced degree (MSc/PhD) in Science
Technologies
Clinical development planning tools, eCRF systems, Statistical analysis software
Responsibilities
Develop clinical development plans and study protocols; Author and review regulatory documents (IB, protocols, clinical study reports); Oversee medical monitoring strategies and blinded data review; Manage external study oversight committees (steering, IDMC); Collaborate with cross-functional teams to translate strategy into operational deliverables; Contribute to scientific publications and conference abstracts.
Seniority
Principal, hands-on IC with strategic oversight