Clinical Research and Development Lead

For one of our partners, we’re hiring several Clinical Research Development Leads to start ASAP.

Description

To participate to Phase I-IV Clinical Development activities within a program or group of related programs within the context of the internal 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 internal standard operating procedures (SOP).

Key Responsibilities:

1. 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 company in meetings with health authorities and the scientific community, net-work with thought leaders and international agencies as needed.

2. 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).

3. 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.

4. 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.

5. Provides support to Marketing/Business Development throughout product life cycle

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

6. Show active follow-up the product-related Environment

• Collect scientific information and review internal project related documents and publications.

Requirements

Your profile:

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

Area of Specialisation:

Previous experience in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, pharmacoepidemiology, and/or clinical vaccinology is a big asset!

You have excellent command of English (oral and written)

Offer

You’ll be offered aModis permanent full time contract with a complete salary package.

Contact

Somemore questions? Don’t hesitate to contact me! Sybille at 02/801.16.65

And ifyou fit the requirements:send yourCV with a cover letterat sybille.ponet@modisbelgium.be