Clinical Project Lead
il y a 1 semaine
Site Name:
USA - Massachusetts - Cambridge, Belgium-Wavre, GSK House, Italy - Siena, Rockville Vaccines
Posted Date:
Mar 4 2024
Position Summary
The
Senior Director, Clinical Project Lead (CPL) leads the Clinical Development Program(s) for one asset or a portfolio of assets.
The CPL provides integrated and innovative clinical development strategy to support the creation and management of the Integrated Evidence Plan (IEP).
The CPL is accountable for the development, execution, and oversight of Phase I through IV clinical studies, including the integration of global considerations into strategic decisions.
The CPL ensures alignment of the Clinical Development Plan (CDP) with the overall Assent Plan, and overall strategic product development.
The CPL works in collaboration with the Vaccine Clinical Science Cluster Head to ensure high scientific rigor and quality of design in clinical studies.
The CPL ensures the incorporation of regional input into global CDPs.The CPL ensures the protocols, reports, publications, and clinical regulatory documents are of highest scientific, operational, and ethical standards and are completed in time and on budget.
The CPL collaborates with Quality and Compliance to ensure high quality execution of the CDP. The CPL is accountable for the medical and human safety aspects of the clinical programs.Key Responsibilities
- Manages the team of Clinical Science Leads (CSLs) and Senior Clinical Science Leads (SCSLs), assigned to the development program, who lead the clinical matrix teams responsible for clinical study activities, including study design, protocol development, input into statistical analysis plans, medical data cleaning and reconciliation, data analysis and interpretation, in compliance with Good Clinical Practice (GCP) and GSK policies and procedures.
- Accountable for the study design and serves as the Clinical Sponsor Signatory for the protocol.
- Accountable for the final analysis and interpretation of clinical trial data and serves as the Clinical Sponsor Signatory for the clinical study report.
- Serves as the primary point of contact for clinical with the Principal Investigators (PIs).
- Accountable for the authorship and approval of clinical documents for regulatory submissions, including Clinical Expert Statements, and serves as the Program Clinical Expert for input into regulatory documents/meetings.
- Accountable to ensure disclosure and publication of clinical trial data according to ICJME and relevant GSK policies and guidelines.
- Supports crossfunctional partners as necessary for activities including External Expert (EE) engagement and PI selection. Supports the regional Medical Affairs teams as needed.
- Drives the endtoend integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable/recommended vaccines and successful life cycle management. Accountable for consistently achieving project timelines in global programs with high quality of execution. Participates in key budget/forecast activities in collaboration with Vaccines Clinical Science Excellence Lead, and Clinical Operations Asset Lead to ensure milestones realisation and resource optimisation.
- Champions implementation of innovative methods and processes within clinical plans, encourages others to think differently and come up with business solutions.
- Establishes expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria in CDP.
- Strategic Leadership: Integrates scientific rationale, regulatory requirements, product development plan and commercial goals to optimise clinical study designs aligned with the IEP and CDP.
- Represents the Clinical Science function at the Vaccine Development Team (VDT), Vaccine Commercialisation Team (VCT), and Discovery Project Team (DPT) as applicable. Supports the VDT/VCT/DPT as necessary through provision of thoughtful senior clinical input and technical expertise to global development questions, including contributions to internal and external briefing documents and presentation materials. Serves as the primary clinical voice for the project at governing bodies such as Development Review Board (DRB), Research Review Board (RRB) and technical committees such as Global Safety Board (GSB), Protocol Review Board (PRB) and Toxicology Working Group (TWG).
- Collaborates with crossfunctional partners in Preclinical, Technical Development, Global Clinical Operations, Biostatistics, Regulatory Affairs, Medical Affairs, Commercial, Value Evidence and Outcomes, Safety, etc. to ensure effective delivery of the project according to agreed plans.
- If requested, involved in the development and execution of external collaborations. May be requested to support business development activities, including the performance of due diligence reviews.
- Plays an active role in the technical and leadership development of Clinical Sciences staff and maintains ov
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