Principal/Associate Director, Physician – Cell Therapy
AstraZeneca
full-time
Posted on:
Location Type: Office
Location: Shanghai • China
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Job Level
About the role
- 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
Requirements
- 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
- Health insurance
- Flexible working arrangements
- Professional development opportunities
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical study deliverymedical monitoringprotocol developmentsafety reportingrisk management plandata analysiscompound knowledgeregulatory guidancePK/PD programsclinical trial landscape
Soft skills
presentation skillscommunication skillsattention to detailanalytical skillsstrategic directioninterpersonal skillsleadershipcollaborationconsultationproblem-solving
Certifications
M.D.Ph.D.