Senior/Principal Physician, Cell Therapy

AstraZeneca

Senior/Principal Physician overseeing clinical studies in the area of Cell Therapy at AstraZeneca. Responsible for medical monitoring, protocol design, and compliance with regulatory standards.

Posted 5/26/2026full-timeShanghai • 🇨🇳 ChinaSeniorWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

clinical study deliverymedical monitoringprotocol developmentdata analysissafety reportingrisk managementcompound knowledgeregulatory guidanceclinical pharmacologyPK/PD programs

Soft Skills

presentation skillscommunication skillsattention to detailanalytical skillsstrategic directioninterpersonal skillsleadershipcollaborationconsultationproblem-solving

Certifications & Qualifications

M.D.Ph.D.

Industry Keywords

clinical researchpharma industryCell-TherapyImmunologyOncologyregulatory complianceclinical trial landscapeKOL interactionadvisory boardChina development strategy

About the role

Key responsibilities & impact

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
Lead discussions with regulatory officials on clinical science subjects of a given project
Provide consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators
Represent TA Clinical Science in China Product Team
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.

Requirements

What you’ll need

Major in Clinical Medicine and 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.

Benefits

Comp & perks

AstraZeneca embraces diversity and equality of opportunity.
Committed to building an inclusive and diverse team.