Job Responsibilities: Program/Trial Planning, Execution, and Reporting
Responsible for leading the translation of scientific concepts into program and study design.
Responsible for identifying and implementing (non-medical) scientific aspects of the program and/or study at planning, execution, and reporting, including (but not limited to) integration of:
Biomarkers
Data Science/Digital Health initiatives
Oversees the assessment, selection, and operational implementation for:
Biomarkers
Digital and other endpoints (scales)
Imaging
Accountable for shaping and implementing compound and program DEI strategy together with the Clinical Leader.
Provides expert input in clinical development plans.
Contributes to the preparation of:
PED
Study protocols
Training materials for clinical studies
Prepares for and participates in:
Protocol Review Committee (PRC) meetings
First in Human (FIH) Committee meetings
Reviews medical and scientific literature.
Along with SRP or Clinical Leader and global development partners:
Responsible for oversight and high-quality implementation and closure of the study
Ensures data integrity
Responsible for the TA review and sign-off on various operational plans.
Responsible for providing scientific input into HA and EC responses.
In concert with operational staff, acts as a liaison between the company and clinical investigators for overarching scientific guidance and other potential non-medical aspects.
Works closely with:
Data Sciences
Data Management
Statistics
Programming
JJIT
Other relevant teams to ensure data is received in the manner needed to support trial outcomes.
Responsible for the review of data to:
Ensure quality
Identify data quality trends
Sets up and leads adjudication activities.
Leads data visualization (DV) meetings and ensures decisions are documented.