Clinical Project Lead - Early Development
Site Name: USA - Maryland - Rockville, GSK House, Siena, Wavre
Posted Date: Feb 3 2023
Clinical Project Lead - Early Development
We are one of the world’s largest vaccines companies. Our portfolio of more than 20 vaccines helps protect people from a range of diseases throughout their lives, including pneumococcal disease, meningitis, hepatitis, rotavirus, whooping cough, and influenza in over 160 countries.
The vaccines in our portfolio have been helping protect people from serious disease for over 100 years and today generate sales of £7 billion (2020). Our strategy is to bring differentiated and high-quality vaccines to as many people as possible. To achieve this, we focus on creating a strong patient and payer-focused pipeline, maintaining valuable partnerships in the countries where we operate, and ensuring sustainable access and affordability.
At GSK, we're driving scientific innovation to deliver the next generation of transformational medicines and vaccines for patients. Within our Vaccines R&D organization, we're now focused on specific disease areas and as a result we are excited to announce a new Clinical Project Lead (CPL) vacancy, focused on early development within our Therapeutic vaccines cluster.
The 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). Accountable for the development, execution, and oversight of Phase I through IV clinical studies, including the integration of global considerations into strategic decisions. Ensures alignment of the Clinical Development Plan (CDP) with the overall Assent Plan, and overall strategic product development. Works in collaboration with the Vaccine Clinical Science Cluster Head to ensure high scientific rigor and quality of design in clinical studies. Ensures the incorporation of regional input into global CDPs. Ensure that the protocols, reports, publications and clinical regulatory documents are of highest scientific, operational and ethical standards and are completed in time and on budget. Collaborates with Quality and Compliance to ensure high quality execution of the CDP. Accountable for the medical and human safety aspects of the clinical programs.
- Manages the team of Senior Clinical Science Leads (SCSLs), and CSLs, assigned to the development program, who Leads 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 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, 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 Vx Clinical Science Excellence Lead, and Clinical Operations Asset Lead 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 commercial goals to optimize clinical study designs aligned with the IEP and CDP.
- Represents the Clinical Science function at the Vaccine Development Team (VDT), Vaccine Commercialization 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 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, 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.
- Play an active role in the technical and leadership development of Clinical Sciences staff and maintains oversight and strategic intent of the program. Ensures effective coaching and mentorship of more junior members of the clinical team.
- Core member of the Vx Clinical Science Cluster Leadership Team.
- MD with the ability to independently conduct clinical research.
- PhD in a relevant field is an asset.
- Previous experience in the field of infectious diseases, internal medicine, paediatrics, obstetrics and gynaecology, clinical epidemiology, pharmacoepidemiology, immunology and/or clinical vaccinology is an asset.
- Minimum 7 years of work experience in vaccine clinical research, or related field, of which at least 5 years of experience in the Industry. 10 years’ experience preferred.
- Extensive knowledge and understanding of vaccines, clinical research, translational science, and biomedical research regulation, including ICH and GCP.
- Knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape.
- Proven track record of managing complex programmes.
- Excellent people and team management skills.
- Strategic thinking skills and achievement oriented.
- 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.
- Strong leadership, coalition-building and communication skills.
- Excellent knowledge of spoken and written English.
- License to practice medicine and board and/ or professional certification is an asset.
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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