Clinical Research & Development Lead, GSK/Curevac collaboration

Site Name: UK - London - Brentford
Posted Date: May
GlaxoSmithKline and CureVac's collaboration, building on our existing relationship, is focused to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. If you're energized by the opportunity to contribute to our commitment to the mRNA space, this Clinical Development Director (Clinical Research & Development Lead) could be the opportunity for you!

As the Clinical Research & Development Lead (CRDL) you will participate in Phase I-IV Clinical Development activities within a program or group of related programs within the context of the GSK Vaccines process in order 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).

Key Responsibilities include: 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 and Epidemiology Research & Development Project Lead (CEPL). Bear primary responsibility and accountability for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including the Investigator's Brochure and the Clinical Study Report. Analyze and interpret the results as a subject matter expert. Supervise the study conduct, and serve as the accountable for the overall delivery of the clinical trial. Assure that results meet the highest standards of quality and ethical conduct. Provide support to the Independent Data Monitoring Committee (IDMC). Completes 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 Clinical and Epidemiology Research & Development Project Lead in representing GSK Vaccines in meetings with health authorities and the scientific community, net-work with thought leaders and international agencies as needed.

Serves as a scientific and management reference for the project (internally/externally): Assumes accountability for the medical/legal and human safety aspects of the clinical study. (If not an MD, assembles and transmits timely summaries of clinical safety data for review by 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 program. Address scientific and medical issues related to one or more clinical studies. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals. Liaise with PV to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and Periodic Safety Updated Reports (PSUR) and serves on SRT (Safety Review Team), as applicable. In clinical studies, together with PV analyse safety and potential signals and escalate accordingly. Publishes clinical data in peer review journals and presents in external scientific meetings / congresses. Maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology. Supports internal process improvement activities and initiatives. Liaise with the Regional Evidence Generation team to ensure alignment of clinical trial activities (includes but not limited to, scientific and medical issues as well as subject's 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. May be delegated by Clinical and Epi Project Lead or Senior CRDL to lead the Clinical Project Team.

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.

Provides support to Marketing/Business Development throughout product life cycle Provide medical support to Marketing/Business Development in order to achieve Company's objectives.

Show active follow-up the product-related Environment Collect scientific information and review GSK Vaccines project related documents and publications.

Basic Qualifications:

• MD or PhD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology.
• Previous experience in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, pharmacoepidemiology, and/or clinical vaccinology is an asset.
• 5 years experience working in a scientific or medical institution (if not an MD, prior experience as Principal Investigator, Medical Monitor or commensurate to Clinical Research Scientist position)
• 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 is an asset.

Preferred Qualifications:

• License to practice medicine and board and/ or professional certification is an asset.
• Previous vaccinology experience highly desirable.

Why GSK?

We balance our focus on a robust pipeline with the active life-cycle management of our existing vaccines, seeking to protect more people through expanding indications and delivering our vaccines to new geographies. Our Innovation ambition is to lead the industry by disrupting vaccines' discovery, development, and manufacturing. We will focus on accelerating critical assets in our pipeline and looking at innovative technologies to unlock potential in emerging fields. Using our industry-leading science, we will accelerate the delivery of our most promising assets to serve the most significant unmet medical need. We want to change the world with our science.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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