* Provides Medical leadership of all for utilization management, cost containment, and medical quality improvement activities.
* Performs medical review activities pertaining to developing and executing (Phase I/II - III) clinical strategy and dev. Plans.
* Report study program updates (clinical, scientific data, regulatory submissions, financial, achievement & risk and mitigation
plan) to Chief Medical Officer and Sr. Vice President of Oncology
* Provides competitive intelligence and market/industry influence and/or implication to assigned therapy
* Developing clinical science information`s for inclusion into annual and strategic Life Cycle Management Plan (LCMP) and
Integrated Development Commercialization Plan (IDCP)
* Working with internal and external healthcare partners, stakeholders, PIs, Clinical Scientists, KOLs, regulatory, business
to develop/maintain measurement indicators
* Working with CST in providing clinical science input and guidance on early development studies
* Lead and ensure that all Clinical Research strategy and clinical Pans within the responsibility Development Groups are
developed and managed in terms of........
* Provide overall management of clinical trials, early development studies, review Phase I-III protocols,..as assigned
* Developing and review PV documents, statistic analysis plan (SAP), study reports, and other regulatory documents, clinical
strategic plan (CSP), and development plans (CDP)
* Leads and support clinical partners in transitioning of indications into Phase III or publication studies. (Developed and
Reviewed Phase II/III protocols and/or provided CD input)
* Developing product safety profile, clinical sections of IB, , and others
* Conduct site and CRO selection, investigator and patient recruitment, point-of-contact for CROs
* Performs medical monitoring; conducted ongoing review of medical/safety data's
* Update and develop PSURs, ASR, DSUR, and reviewed medical writing
* Measures and monitor study progress against objectives; provided mitigation plans
* Perform medical monitoring, medical data review, safety data review, RMP, and chair DE Meetings with PIs and team
* Developing health authorities submission documents, Pediatric Investigational Plans (PIP), Post-Marketing commitment
(PMC), documents to FDA
* Developing communications strategies to support existing studies. Includes KOL interactions, advisory boards, medical meetings,
Congresses, publications and other materials
* Provides input for regulatory submissions and processes; developed label & packaging language.