Executive Medical Director, Clinical Development Lead – Hematology
United States
Full Time
1 day ago
H1B Sponsor
Key skills
LeadershipCollaborationRemote Work
About this role
Role Overview
Act as the single point of accountability for clinical development plans (CDPs) of an asset.
Oversight of disease strategies, indications and associated clinical trial program/study data and integrity.
Participate as a core member of the Medicine Development team or Early Development Team.
Accountable for overall benefit:risk of a clinical program.
Lead cross-functional Clinical Matrix Team and provide clinical leadership, Oncology Clinical Development expertise, and customer insight for the program.
Guide direct reports to ensure cross-functional integration, coordination, collaboration, and alignment to enable effective and efficient CDP execution.
Contribute strategic guidance and highlight clinical considerations to inform portfolio development strategies, individual study design and conduct, combination strategies, and disease area strategies.
Interpret complex clinical data and identify trends for clinical and regulatory documents consult on safety analyses, and responses to health authority queries.
Prepare for governance discussions in close collaboration with cross-functional Medicine Development Leader (MDL).
Requirements
Medical degree with completion of a formal primary medical clinical training program
Advanced pharmaceutical clinical research experience in field of Hematology/Oncology.
Experience in clinical research and drug development with a focus in multiple myeloma
Matrix team experience within a clinical development setting
Experience preparing clinical oncology sections for regulatory submissions and responding to health authority questions
Experience working with oncology external investigator networks and leading advisory or investigator meetings.
Robust knowledge of Oncology treatment guidelines, therapeutic competitive landscape, clinical development process and drug approval process in major regions.
Cross-functional oncology medicine development knowledge and business acumen.
Track record of scientific publications, abstracts or presentations from clinical studies.