AstraZeneca
Pharma
PhysicianII(CellTherapy)
Neural analysis suggests this role is
optimal for Senior candidates.
“Physician II (Cell Therapy) at AstraZeneca. Skills: Cell Therapy, Clinical studies, Regulatory filing. Ensure conduct and integrity. Co-owners of clinical study delivery”
Industry & Context.
Analytical skill
What They're Looking For.
Must Have
Minimum 6 years clinical research, Therapeutic area expertise, Compound knowledge, Regulatory guidance, Medical monitoring, Safety reporting, Risk Management Plan, CSP/CSR content, Data analysis
Nice to Have
Cell-Therapy/Immunology/Oncology expertise, Presentation skill, Communication skill, Prioritize and focus, Attentive to detail, Excellent analytical skill
What You'll Do.
Ensure conduct and integrity
Co-owners of clinical study delivery
Development documents content owner
Analysis and interpretation of results
Forming and running advisory board
Interacting and communicating with KOLs
Liaise with safety physician
Liaise with clinical pharmacologist
Protocol development preparation
Setting strategic direction
Supporting China regulatory filing
Leading discussions with regulatory officials
Providing consultation to colleagues
Answering protocol related questions
Representing TA Clinical Science
Interface with GPT MSD/physicians
Provide clinical science support
Support pre-launch marketing activities
Maintain medical/scientific knowledge
Maintain clinical trial landscape
Maintain competitive intelligences
How You'll Work.
Team & Collaboration
China KOLs; Safety physician; Clinical pharmacologist; Clinical Challenge Committee; Protocol Review Committee; China Product Team; GPT MSD/physicians; MA and BD
Communication Scope
Presentation; Communication
Full Job Description
**Typical Accountabilities:** * 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 **Education, Qualification
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