About this role

Provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical program in Hematology Oncology
Manages all operational aspects and drives execution of clinical programs in partnership with global line functions
Leads interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders)
Ensures overall safety of the compound in collaboration with the Safety Lead
Contributes to CRF’s, outsourcing specifications, data monitoring and validation plans, analysis plan for all trials
Leads development of clinical sections of program level regulatory documents

A M.D. degree, preferably with clinical training in a relevant disease area
More than 4 years' demonstrated experience in clinical research or drug development in an industry environment spanning clinical activities in Phases 1 through 4
Understand global regulatory environment including key regulatory agencies and approval processes
Have a strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)
People Management experience preferred but not required.

Senior Medical Director, Clinical Development – Hematology Oncology

Key skills