Director Study Leader, Cell Therapy
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Apply Now Application ends in 25d 11h 49min
Job Detail
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Offered Salary 0
Job Description
Accountabilities
- Provide clinical operational input into project or study level documents and may lead the delivery of study documents.
- With oversight from the Clinical Program Director, Cell Therapy, lead and deliver outstanding and operational options for review at Investment Decision Governance interactions.
- Lead the delivery of clinical study(s) or program(s) from concept to final CSR and through to study closure and archiving, ensuring adherence to budget, time, project standards, quality, and scientific standards.
- Optimize the performance of study delivery teams ensuring GCP compliance, including providing accurate performance feedback for study team members to the appropriate AZ manager or CRO representative.
- Maintain oversight throughout the life of the study or program, ensuring overall deliverables are met.
- May have 5 direct/indirect reports.
- Implement agreed study level processes and technology for assigned Cell Therapy clinical studies.
- Lead risk management/mitigation plans to ensure delivery to quality, budget, and time, raising issues to partners as necessary.
- Provide input to forecasting and management of study delivery costs, resources, and timelines.
- Ensure quality of study/program planning information into relevant planning systems (e.g., PLANIT) in collaboration with counterparts in relevant therapeutic areas.
- Guide the Study Team in developing outsourcing specifications and vendor selection.
- Provide procurement with clear specifications for study or program-specific outsourcing.
- Review and operationally approve study or program-specific contracts or work orders.
- Lead all aspects of CROs and other clinically outsourced third-party vendors.
- Communicate study level reports and status updates for assigned Cell Therapy studies, including progress issues
- Lead risk management and quality efforts to ensure study compliance and inspection readiness for apheresis and cell therapy infusion activities.
- May lead study delivery-related activities associated with regulatory inspections/audits in liaison with Clinical QA for apheresis and cell therapy infusion activities.
- Contribute to operational interactions with external entities including regulatory agencies, preferred partners/suppliers, and external collaborators.
- Responsible for the submission of essential documents to the Trial Master File, maintenance, and final closeout.
Essential Skills/Experience
- BS degree in related field or biological science
- 10 years drug development experience
- 5 years leading studies/programs in clinical development
- 3 years of direct Cell Therapy experience
- Clinical drug development process knowledge
- Leading delivery through internal and external organizations
- ICH-GCP principles
- Selection and oversight of external providers and development/providing clear requirements of contracts
- Early phase clinical delivery and in autologous or allogeneic therapies in oncology
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Application ends in 25d 11h 49min