MEDICAL DIRECTOR, HEMATOLOGY
Objective of Position:
The Medical Director, Hematology oversees the direction, planning, execution, and interpretation of clinical trials and the data collection activities.
Essential Duties/ Responsibilities
Directs protocol implementation including site identification and communication, attendance at investigators meetings, correspondence with sites including IRBs and interaction with operations teams
Manages program development, including working cross-functionally with all of the disciplines necessary for successful drug development: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management, pharmacovigilance, and clinical operations Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration
Monitors clinical trials including the oversight of all aspects of trial conduct and safety, contact with investigators and site study staff
Supports data analysis and assembly, including clinical study report writing, contributes to the preparation of abstracts, presentations, and manuscripts
Supports commercial teams, through the communication of medical issues to the commercial group, and by helping to formulate medical opportunities for the marketing team Interacts closely with Medical Affairs in support of ISTs and publications Interacts closely with the Regulatory group and regulatory agencies, taking part in IND submissions, investigator brochure authorship and communication with US and international regulatory agencies
Interacts closely with the Regulatory group and regulatory agencies, taking part in IND submissions, investigator brochure authorship and communication with US and international regulatory agencies
Demonstrated independence, initiative and the ability to work well in a fast-paced environment
Travel time is approximately 15% including visits to investigative sites, regulatory agencies, and attendance at major oncology meetings
MD Minimum three years of industry experience
Sub-specialty training in oncology and/or hematology preferred
Outstanding academic achievement and significant clinical trial experience preferred
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