What we offer

Joining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Job Description

Keyrus Life Science is looking for 2 Clinical Research and Development Leads  to join our consulting team for a client project based in Wavre. 

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

Your challenges will be : 

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 our client in meetings with health authorities and the scientific community, net-work with thought leaders and international agencies as needed.
  
  Serve as a scientific and management representative for the project
• 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 as a core member of the clinical project team and contribute to achievement of team objectives.
• 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 labeling.
  
  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 project related documents and publications
   

Profile

• 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.
• 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)
• Role requires the ability to translate scientific skills in the field of vaccines and clinical research into business driven strategies. Understanding of GCP and ICH guidelines; experience working with Regulatory functions (i.e. filing IND, BLA,
  CTD) a plus
• 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.
  

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skilfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.