Are you energized by an opportunity to accelerate and deliver a Clinical Sciences Strategy that drives compliance and efficiency? If so, this Associate Director, Clinical Sciences Lead (CSL) role could be an exciting opportunity to explore.

Innovation is the beating heart of our business. Without it, there will be no new vaccines for the many diseases that still threaten individuals, families, and communities around the world.

Our Vaccines scientists work in three global R&D centers, in Belgium, Italy, and the USA – and a fourth virtual R&D centers dedicated to mRNA technology. We are focused on discovering and developing novel vaccines across a range of pressing public health threats. Our efforts are concentrated on those possible vaccines which may offer significant improvements over existing options or target diseases for which no vaccines yet exist.

Our approach is to make the most of our own expertise and experience, while at the same time forming complementary partnerships and alliances with others who bring different kinds of expertise. Our vision for the world, where everyone has access to the vaccines they need, depends on a steady supply of great ideas and brilliant science. We have much to offer and through collaboration we can achieve so much more.

We currently have an opportunity for Associate Director, CSL to join our CMV Vaccines team. Reporting to the Senior Director, Clinical Project Lead (CPL) you will conduct Phase I-IV Clinical Development activities within our innovative CMV Vaccine Program to lead Clinical Development activities for studies to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and GSK Vaccines standard operating procedures (SOP).

Associate Director, Vx Clinical Sciences Lead (CSL), CMV Vaccines

To conduct Phase I-IV Clinical Development activities within a program or group of related programs within the context of the GSK process to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and GSK standard operating procedures (SOP).

In this role you will:

Participate in Clinical Development activities for a study or several studies within a specific program or group of related programs.

• Design clinical trial protocols, and author clinical study reports and publications of high scientific, operational, and ethical standards. Ensure consistency of data within program and across projects. Reporting accountability to Clinical Project Lead (CPL).
• Be ultimately accountable end to end for any step of a clinical study, clinical trial synopses, and protocols and all clinical trial documents, including the Investigator’s Brochure and the Clinical Study Report.
• Bear primary responsibility and accountability for scientific and medical quality of clinical studies.
• Analyze and interpret the results as a subject matter expert.
• Assure that results meet the highest standards of quality and ethical conduct.
• Support to internal Safety Review Team (iSRC) and/or Independent Data Monitoring Committee (IDMC).
• Participate as core member to clinical study teams
• Complete tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience.
• Support where applicable the CPL in representing GSK in meetings with health authorities and the scientific community, network with thought leaders and international agencies as needed.

Serve as a scientific and management reference for the project (internally/externally)

• Assume accountability for the medical/legal and human safety aspects of the clinical study. (If not an MD, assemble and transmit timely summaries of clinical safety data for review by a competent medical officer).
• Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within the program.
• Address scientific and medical issues related to one or more clinical studies promptly. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals in a timely manner.
• Liaise with Safety to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and other aggregated periodic safety reports and serve on SRT (Safety Review Team), as applicable. In clinical studies, together with Safety, analyze safety and potential signals and escalate accordingly.
• Publish clinical data in peer review journals and present in external scientific meetings / congresses.
• Maintain and expand knowledge in medical and scientific competencies (as appropriate), vaccinology, and trial methodology.
• Support internal process improvement activities and initiatives.
• Liaise with the Global Clinical Delivery team to ensure alignment of clinical trial activities (includes but not limited to, scientific and medical issues as well as subjects’ safety).

As a member of the Clinical Project Team, always actively participate and engage within the project matrix.

• Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.
• Be delegated by Clinical Project Lead or Senior Clinical Sciences Lead to lead the Clinical Project Team, if necessary.

Actively participate in preparing the clinical portion of the regulatory files and the registration process

• Contribute to development of clinical section of regulatory files, including labelling.

Provide support to Marketing/Business Development throughout product life cycle

• Provide medical support to Marketing/Business Development to achieve Company’s objectives.

Show active follow-up in the product-related environment

• Collect scientific information and review the CMV Vaccine project related documents and publications.

Why you?

Basic Qualifications

• MD and/or PhD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology/immunology.

Preferred Qualifications

• MD and/or PhD specializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or pharmacoepidemiology. Previous experience in clinical vaccinology is an asset. Minimum 1 year industry experience or minimum of 5 years’ experience working in a scientific or medical institution.
• Basic knowledge and understanding of vaccines, clinical research, and biomedical research regulation, including ICH and GCP.
• Working knowledge and understanding of causes of infectious diseases, health interventions, and the global public health landscape.
• Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum.
• Strategic thinking skills and achievement oriented.
• Able to critically analyze information, identify strengths and weaknesses of approaches, and develop remedial actions to mitigate risks.
• Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences.
• Excellent knowledge of spoken and written English.
• License to practice medicine and board and/ or professional certification/eligible is an asset.

#LI-GSK

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 positively impact the health of 2.5 billion people by the end of 2030.

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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