Early Development Project Leader - Cambridge
1 month ago
Job summary
We are an innovative global healthcare company seeking an Early Development Project Leader to shape the future of medicine by accelerating drug discovery and development. As a key member of our team, you will plan, execute, and finalize clinical trials operations while ensuring compliance with relevant regulations.Responsibilities
- Plan, execute, and finalize clinical trials operations
- Develop the operation plan
- Lead the cross-function study team and oversee entire processes including preparing protocols recruiting subjects collecting valuable data managing budgets timelines work with medical leads data managers statisticians clinical supplies managers regulatory affairs specialists etc ensure compliance with relevant regulations such as Good Clinical Practice GCP internal SOPs contribute to development new drugs medical devices through clinical trials May be core team member Global Project Team GPT representing accountable CSO deliverables preparation attendance TARC DWG scope early phase development e g pre candidate POC POCC Co-Leads JCOT Joint Clinical Operations Team Medical Lead leads Clinical sub-team if exists Responsible accountable early development project deliverables Responsible optimizing early development operational strategy implementation realization FIM POC POCC studies based input applicable functions CSO create most value project team platform operational tasks Contribute process improvement efforts taking clear action foster innovation along value chain Steering program research global clinics hand off registration Late Development ensures strong relationships sites collaboration CSU Support late stage compound pilot coordinate early activities including Phase I new POC indications complex design studies primary point contact late phase development teams smooth transition business continuity late development operational teams delegates Previous strong experience early project clinical development entry First Human POC Dose Escalation Dose Optimization Dose expansion complex design Familiar all pre-clinical activities e g Toxicity studies Collaborates upfront CSCO Demand Supply Leader CMC Leader secure aspects linked IMP e g use study anticipation pharmacy manual IP delivery Supports BMOM TMED.
Job description
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