The Clinical Research Scientist, Translational Development, leads the tactical support efforts of Early Development clinical trials from a clinical science perspective. This function works in collaboration with the Medical Monitor responsible for clinical trial oversight in hematology and oncology indications to effectively lead and implement Translational Development compound strategy. This function is accountable for working closely with the project and study teams to deliver enhanced efficiencies and quality around tactical deliverables, including IND and other regulatory submissions, protocol development, amendments and other supporting clinical documents (eg. case report forms), PK/PD and clinical data collection and analysis, investigator and site communications, study reports and publications.
Responsibilities include, but are not limited to, the following:
•Represent Translational Development in cross functional teams/meetings (e.g. Project Teams, Study Sub-teams, Safety Review Committees and Management Teams, etc.).
•Collaborate with project and functional teams in Translational Development on compound strategy and tactics and development of Translational Development Product Development Plans.
•Support cross-functional sub-team meetings in collaboration with the Medical Monitor.
•Author, develop, and amend clinical study protocols, consent forms, case report forms and ancillary documents in collaboration with the Medical Monitor and study teams.
•Oversee the preparation of a clinical development research plan (CDRP) that outlines the seminal ...cont.