Clinical Research and Development Lead
Business Unit Manager
+32 497 71 58 10
- To participate to Phase I-IV Clinical Development activities within a program or group of related programs within the context of the organisations 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 standard operating procedures (SOP).
- Participate in Clinical Development activities for a study or a number of 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 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.
- Analyse 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.
- Support to 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 the organisation 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 subjects safety).
- As a member of the Clinical Project Team, always actively participate and engage within the project matrix.
- Actively participate in preparing the clinical portion of the regulatory files and the registration process
- Provides support to Marketing/Business Development throughout product life cycle
- Show active follow-up the product-related Environment
- Preferred Level of Education MD 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.
- You have a sound scientific background and are able 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.
- Minimum 1 year industry experience or minimum 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.
- experience working with Regulatory functions (i.e. filing IND, BLA, CTD) a plus
- You have the ability to translate scientific skills in the field of vaccines and clinical research into business driven strategies.
- Ability to work well within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills.
- Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence.
- 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 analyse 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.