oncology/hematology studies.
* Ensure that scientific rigor and innovation continues to be
integrated into and drives Kura Oncologys development strategies.
* Ensure excellence in both strategy and execution by partnering
closely with clinical operations, biostatistics, data management,
program management, and research colleagues.
* Serve as Medical Monitor of sponsored clinical research and as
medical representative to CROs, reference laboratories and other
organizations involved in the execution of clinical trials.
* Responsible for of all clinical regulatory deliverables and other
clinical documents associated with the clinical trials under his/her
direct responsibility, including protocols, and the clinical portion
of INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSRs
and clinical expert reports, among others.
* Responsible for the analysis of clinical data, including safety
monitoring in collaboration with PV.
* Participate in site initiation visits and other site visits at
clinical center.
None
WORK ENVIRONMENT:
* Lead cross-functional clinical teams for the design and conduct of
oncology/hematology studies.
* Ensure that scientific rigor and innovation continues to be
integrated into and drives Kura Oncologys development strategies.
* Ensure excellence in both strategy and execution by partnering
closely with clinical operations, biostatistics, data management,
program management, and research colleagues.
* Serve as Medical Monitor of sponsored clinical research and as
medical representative to CROs, reference laboratories and other
organizations involved in the execution of clinical trials.
* Responsible for of all clinical regulatory deliverables and other
clinical documents associated with the clinical trials under his/her
direct responsibility, including protocols, and the clinical portion
of INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSRs
and clinical expert reports, among others.
* Responsible for the analysis of clinical data, including safety
monitoring in collaboration with PV.
* Participate in site initiation visits and other site visits at
clinical center.
None
WORK ENVIRONMENT:
We need : English (Good)
Type: Permanent
Payment:
Category: Others
