GLOBAL DEVELOPMENT SENIOR MEDICAL MANAGER II
Medical/Late Development Oncology components (benefit-risk evaluation) of periodic reports such as Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) and annual New Drug Application (NDA) reports, license renewals, labelling and regulatory responses (in collaboration with other team members) under the direction of the Global Clinical Program Leader (GCPL) or delegate Senior Medical Lead (SML)
Works with international colleagues and with external Alliance partners on regulatory requests/issues
Applies strategic intent of AstraZeneca when working with Alliance partners and Regulatory Authorities
Able to serve as a source of medical expertise for the Product Team
Able to provide guidance for investigator-initiated trials by providing clinical and scientific expertise/inputs into protocols, clinical study reports.
Able to act as Global Clinical Leader delegate on assigned tasks.
As assigned by GCPL, responsible for the relevance and accuracy of clinical science underpinning LCM project related clinical development activities in support of regulatory approval and market access globally
As assigned by GCPL, contributes to the development of Medical Oversight Plan (MOP), study level safety reviews, and study-level medical monitoring activities in Phase III studies
As assigned by GCPL, responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests in Phase III studies
Is accountable to GCL (or delegate) and Late Development Oncology leadership for identifying risks and proposing mitigation strategies to enable a successful execution of License-to-Operate tactics
Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws
ESSENTIAL SKILLS REQUIRED
Graduate/Post-Graduate of a recognized school of medicine with an M.B.B.S.,M.D. degree or equivalent..
Industry or academic experience in drug development required.
Possesses detailed knowledge of GCP and other regulations governing clinical research.
Ability to grow and maintain a high level of expertise in oncology therapeutic area.
Demonstrates solid understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.
≥3 years clinical research expertise in relevant therapy area or CRO experience
Good knowledge of biostatistics, global regulatory environment and pharmacovigilance
Proven teamwork and collaboration skills
Good presentation skills with fluency in oral and written English
Can communicate effectively with internal and external collaborators
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