Site Name: Italy - Siena, Belgium-Wavre, GSK HQ
Posted Date: Jun 26 2024
Clinical Project Lead, CPL – Vaccines Global Health Position Summary The CPL oversees the entire Global Health Vaccines R&D Clinical Development Programs. They provide integrated and innovative clinical development strategy to support the creation and management of the integrated evidence plan (IEP), and are accountable for the development, execution and oversight of PI through to PIIb clinical studies, including the integration of global considerations into strategic discussions. The CPL also develops a PIII clinical strategy aligned with all GH stakeholders which optimises strategic fit with potential PIII collaborators and ensures alignment of the Clinical Development Plan (CDP) with the overall Asset Plan, and overall strategic product development. Working in collaboration with the Head of Clinical Development & RA (HCDRA) to ensure high scientific rigor and quality of design in clinical studies. Ensures the incorporation of regional input into global CDPs. Ensures that the protocols, reports, publications and clinical regulatory documents are of highest scientific, operational and ethical standards and are completed on time and on budget. Collaborate with Quality and Compliance to ensure high quality execution of the CDP. Key Responsibilities ·Manages the team of Senior Clinical Physicians, 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 / GVGH 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. ·Serve 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 cross-functional partners as necessary for activities including External Expert (EE) engagement and PI selection. Supports the regional Medical Affairs teams as needed. ·Drives the end to end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, . Accountable for consistently achieving project timelines in global programs with high quality of execution. Participates in key budget/forecast activities in collaboration with Finance Clinical Operations Asset Lead and appropriate functions to ensure milestones realization and resource optimization. ·Champion 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 impact goals to optimize clinical study designs aligned with the IEP and CDP. ·Represents as needed the Clinical Sciences function at the Vaccine Development Team (VDT), Pre-Clinical Teams, Access Teams, as applicable. Supports said teams/ 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 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 cross-functional partners in Preclinical, Technical Development, Global Clinical Operations, Biostatistics, Regulatory Affairs, Medical Affairs, 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. Basic Qualifications ·MD with previous experience within clinical development. ·Knowledge and understanding of vaccines, clinical research, translational science and biomedical research including ICH and GCP. ·Knowledge and understanding of causes of infectious diseases, health interventions and the global health landscape. ·Proven track record of managing complex programmes. ·Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum. ·Leadership, coalition-building and communication skills. ·Excellent knowledge of spoken and written English. Preferred Qualifications ·Licence to practice medicine and board and/or professional certification is an asset. ·People and Team Management skills. ·Strategic thinking skills and achievement orientated. ·Able to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks. ·Ability to understand high level corporate and business objectives: rapid, flexible, innovative working and decision making. ·Executive capability with strategic planning & budget processes such as analytical thinking. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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