Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring)
Co-owners of clinical study delivery (with Stats and Clinical Operations)
Development documents (CIB, protocol and CSR, ETC) content owner
Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety (as well as Clinical Pharmacologist if necessary)
Forming and running advisory board for portfolio projects
Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design
Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting
Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables
Protocol development preparation for review by the Clinical Challenge and Protocol Review Committee
Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction
Be a TA clinical science expert and supporting China regulatory filing and registration
Be a TA clinical science expert and leading discussions with regulatory officials on clinical science subjects of a given project
Be the clinical science physician and providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators
A core function on China Product Team representing TA Clinical Science
Be the interface with GPT MSD/physicians on clinical sciences matters
Provide clinical science support to BD and AZ China projects on needed base
Liaise with MA and BD to support pre-launch marketing activities, publications, conferences and early market access to the compounds
Maintain up-to-date medical/scientific knowledge as well as clinical trial landscape and competitive intelligences in the TA