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Physician II, Cell Therapy
AstraZenecaPhysician II responsible for oversight of clinical studies in cell therapy at AstraZeneca. Collaborating with teams and regulators in China to support project goals.
About the role
Key responsibilities & impact- Ensure successful conduct and integrity of all in-scope clinical studies.
- Co-owners of clinical study delivery with Stats and Clinical Operations.
- Development documents content owner.
- Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety.
- 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 and evaluation of safety signals.
- 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.
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.
- We are committed to building an inclusive and diverse team representing all backgrounds.
- We believe that the more inclusive we are, the better our work will be.
- We welcome and consider applications to join our team from all qualified candidates.
- We comply with all applicable laws and regulations on non-discrimination in employment.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical study deliveryprotocol developmentsafety reportingrisk management plandata analysismedical monitoringregulatory guidancecompound knowledgePK/PD programsclinical research
Soft Skills
presentation skillscommunication skillsattention to detailanalytical skillsstrategic directioninterpersonal skillsleadershipcollaborationconsultationprioritization
Certifications
M.D.Ph.D.