Clinical Trial Physician (CTP)
On-siteShanghai, Shanghai, China
Job Summary
Lead ongoing medical review of clinical trial data, including eligibility and key safety data, while driving cross-functional alignment with Clinical Operations, Pharmacology, and Biometrics to ensure robust risk mitigation. Provide end-to-end medical oversight for Phase 1 through Phase 3 studies, including study design, real-time emerging safety signal review, dose escalation decisions, and clinical dossier preparation for regulatory filings. Lead Safety Review Committee and Dose Escalation Committee activities, prepare safety packages, and assess severe adverse events in partnership with Worldwide Patient Safety. Design and develop clinical plans and protocols for early development, ensuring China and global strategy alignment, while partnering with Clinical Scientists to address site medical questions and support study execution. Serve as the clinical point of expertise for Health Authority interactions and advisory board meetings, authoring clinical content for regulatory reports and submission documents.
Required Qualifications
- Medical Monitoring
- Study Delivery Team (SDT)
- Clinical Development Team (CDT)
- ongoing medical review of clinical trial data
- eligibility and key safety data review
- cross-functional alignment with Clinical Operations, Clinical Pharmacology, Translational Medicine, Biometrics, and Worldwide Patient Safety
- timely data review
- robust risk mitigation
- end-to-end medical oversight for Phase 1 FIH dose escalation/expansion to Phase 2 and Phase 3
- study design
- medical monitoring
- data review
- data interpretation
- real-time emerging safety signal review
- DLT assessment
- dose decision support
- Safety Review Committee (SRC)/Dose Escalation Committee activities
- preparation of safety packages
- dose recommendation rationale
- decision documentation
- clinical input and insight to filing strategy
- data interpretation and filing activities
- clinical dossier preparation
- GCP inspection
- Clinical Development Lead
- clinical plans and protocols
- asset/drug knowledge
- disease area expertise
- relevant science
- regulatory and disease strategy targets
- Phase 1 to Phase 3 protocol strategy
- key design elements
- target population
- treatment regimen
- endpoints setting
- intensive safety monitoring
- Investigators Brochure
- nonclinical package
- China and global strategy alignment
- Global Clinical Development
- Global Program Teams
- regional inputs
- consistency of program decisions and messaging
- medical accountability and oversight
- group of studies across early studies
- benefit/risk analysis
- matrix team environment
- Clinical Scientists (CS)
- site activation
- enrollment status
- adjudication of protocol violations and deviations
- early development regulatory interactions
- submissions
- IND/CTA modules
- briefing packages
- clinical/medical author
- reviewer
- Regulatory Affairs
- principal investigators
- thought leaders
- emerging science
- biomarker strategy
- study/program design
- medical/scientific reputation
- disease area
- conference participation
- ongoing literature review
- protocol-specific medical education
- study teams
- investigators
- stakeholders
- Clinical Scientist (CS)
- Health Authority interactions
- advisory board meetings
- global program strategy
- consistency across clinical, regulatory, and safety messaging
- clinical content
- CSRs
- regulatory reports
- briefing books
- submission documents
- study closure
- reporting
- CSs
- 100% of shifts onsite
- assigned facility
- site-essential
- site-by-design
- field-based
- remote-by-design
- occupancy structure
- site-essential roles
- site-by-design roles
- field-based roles
- remote-by-design roles
- hybrid work model
- 50% onsite
- assigned facility
- onsite presence
- essential job function
- collaboration
- innovation
- productivity
- positive Company culture
- physically travel
- visit customers
- patients
- business partners
- attend meetings
- BMS
- directed
- people with disabilities
- reasonable workplace accommodations/adjustments
- ongoing support
- recruitment process
- qualified applicants
- arrest and conviction records
- applicable laws
- Los Angeles County
- GCP and compliance obligations
- clinical conduct
- required training
- Clinical Development Expertise & Strategy
- Health Authority Interactions & Publications
- Protocol
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