Company

Senior/PrincipalPhysician(CellTherapy)

China FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Senior/Principal Physician (Cell Therapy). Skills: Cell Therapy, Clinical Research, Regulatory Affairs. Ensure conduct and integrity of clinical studies. Provide medical monitoring”

Industry & Context.

Problems you'll solve

Excellent analytical skill

What They're Looking For.

Must Have

Major in Clinical Medicine, M.D. or Ph.D., Minimum 6 years of experience as clinical research physician in pharma industry, Therapeutic area expertise in Cell-Therapy/Immunology/Oncology, Compound knowledge, Regulatory guidance for the TA, Medical monitoring, Safety reporting and Risk Management Plan, CSP/CSR content & data analysis, Presentation & communication skill, Prioritize and focus with attentive to detail and excellent analytical skill

What You'll Do.

Ensure conduct and integrity of clinical studies

Provide medical monitoring

Co-own clinical study delivery

Own development documents content

Analyze study results

Interpret study results

Form and run advisory board

Interact with China KOLs

Communicate China strategy

Design China protocols

Liaise with safety physician

Evaluate safety signals

Ensure regulatory compliance

Liaise with clinical pharmacologist

Ensure PK/PD deliverables

Prepare protocol for review

Set strategic direction

Address medical issues

Support China registration

Lead discussions with regulatory officials

Provide consultation to colleagues

Answer protocol questions

Represent TA Clinical Science

Interface with GPT MSD/physicians

Provide clinical science support

Support pre-launch activities

Support market access

Maintain medical knowledge

Maintain scientific knowledge

Maintain clinical trial landscape knowledge

Maintain competitive intelligence

How You'll Work.

Team & Collaboration

Co-owners of clinical study delivery (with Stats and Clinical Operations); Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety; Liaise with safety physician for program-level assessment; Liaise with clinical pharmacologist on PK/PD programs; Be 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; Liaise with MA and BD to support pre-launch marketing activities

Communication Scope

Presentation & communication skill

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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