Amsterdam, The Netherlands, Netherlands
Are you looking for a rewarding career in a market-leading and innovative company?
Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create Seqirus, now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries.
Currently for our office in Amsterdam we are looking for a Clinical Scientist
The Clinical Scientist role is a multifunctional, clinical project position in the therapeutic area. The position holder works closely with the Senior and Principal Clinical Scientist, and the (Senior) Global Clinical Program Director and/or Global Therapeutic Area Head performing delegated tasks in support of the clinical development program as dictated by therapeutic area/ project needs.
The position holder contributes to the scientific development of individual clinical studies in alignment with the approved clinical development plan. This includes contribution to and authorship/ review of some clinical documents (protocols, CRFs, ICFs, CSRs, etc.) to ensure that the scientific content/ rigor is consistent and of the highest quality across the clinical development program.
• Contributes to the clinical oversight and medical guidance in collaboration with the Principal Clinical Scientist, and/or (Senior) Clinical Program Director during the conduct of the study.
• Reviews clinical data with some assistance and contributes to the development of clinical presentations and integration of analyses into clinical documents.
• Liaisons with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) and investigators.
• Assists with the planning and monitoring of the timelines, resources and budget for the scientific part of the clinical program (Medical Writing, AdBoards etc).
• Manages the processes required to support external study review committees; e.g data monitoring committees, steering committees.
• Contributes or Leads the development of product related documents (f.ee.g.. DSUR, PSUR, IB)
• Contributes to multidisciplinary task forces to support continuous improvement (i.e. quality circles, SOP harmonization, ACE).
Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with 3+ years experience in clinical research.
· Strong knowledge of clinical research procedures, GCP and SOPs and understanding of drug development process.
· Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
· Involvement in cross-functional, multicultural and international clinical trial teams preferable.
· Experience in medical/regulatory writing preferable.
· Excellent communication skills.
· Ability to work successfully in a matrix organization
· Ability to manage external relationships with Key Opinion Leaders
· Fluent in English, oral and written.