Senior Clinical Research & Development Lead

You have finished your MD or PHD? And you are ready to join an internal company as a Clinical Research and Development Lead ? Then jump in!
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What we offer

Joining our consulting team 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 a Senior Clinical Research & Development Lead to join our consulting team for a client project based in Wavre, Belgium

Your challenges will be : to participate to Phase I-IV Clinical Development activities within a program or group of related programs within the context of the our clients 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 our client 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:

  1. 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).
  2. 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.
  3. Analyse and interpret the results as a subject matter expert.
  4. Supervise the study conduct, and serve as the accountable for the overall delivery of the clinical trial.
  5. Assure that results meet the highest standards of quality and ethical conduct.
  6. Support to Independent Data Monitoring Committee (IDMC).
  7. 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.
  8. Support 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.
  9. Serve as a scientific and management reference for the project (internally/externally), meaning being accountable for the medical/legal and human safety aspects, paying attention to adverse events, Data Listing review, liaise with Pharmacovigilance Department and 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.

  1. Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.
  2. May be delegated by Clinical and Epi Project Lead or Senior CRDL to lead the Clinical Project Team.
  3. Actively participate in preparing the clinical portion of the regulatory files and the registration process
  4. Contribute to development of clinical section of regulatory files, including labelling.
  5. Provides support to Marketing/Business Development throughout product life cycle
  6. Provide medical support to Marketing/Business Development in order to achieve Company’s objectives.
  7. Show active follow-up the product-related Environment
  8. Collect scientific information and review project-related documents and publications.
     

Profile

  • MD or PhD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology.
  • Previous experience of 5 years in clinical trials in the field of infectious/chronic diseases (immunology) or vaccines.
  • Combines analytical competencies partnering with other experts (biostatistics, clinical, medical affairs, regulatory and safety, and others).
    Supports projects in a matrix organisation.
  • Understanding of GCP and ICH guidelines; experience working with Regulatory functions (i.e. filing IND, BLA, CTD) a plus.
  • Excellent knowledge of spoken and written English

 

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 skillfully, 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.

 

Or, know someone who would be a perfect fit? Let them know!

Walloon Brabant

Walloon Brabant
1470 Walloon Brabant Directions

Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.

What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.   

With us, you will be part of our family and feel our human approach culture as of Day 1! 

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