Associate Director, Clinical Sciences Lead
il y a 3 semaines
**Site Name**: USA - Maryland - Rockville, Belgium, Italy
**Posted Date**: May 11 2023
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.
- 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 ap
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