Do you have an innovative mindset and do you enjoy groundbreaking work with impact on the conduct of clinical studies, this vacancy of Translational Sampling Specialist might be your ideal next step!
Your contributions will be valued by a dynamic team in the Infectious Diseases Therapeutic Area of R&D that actively builds on its clinical developmentstrategy by introducing advanced sampling methodologies, processing procedures and advancedsample analysis platforms in clinical studies.
The Translational Sampling Specialist (TSS) is an operational expert and ultimately accountable for all operational aspects associated with piloting and implementation of new sampling methods and procedures.
He/she drives the methodology evolution from an exploratory phase to a stage where themethod development can reliably support both biomarker research and eventually clinical studyendpoint for regulatory submission. The TSS interacts closely with Biomarker scientists and theTranslational Sample Operations Lead. The TSS reports to the Early Clinical Science Director.
The TSS will support a biosample operational team focusing on a established sampling procedure of PBMCs. In a cross-functional team of clinical operations (ClinOps) and immunology subject matter experts of the Clinical Microbiology and Immunology (ClinMI) department of Infectious Diseases, the TSS is responsible for managing several PBMCrelated vendors to support ED and LD clinical studies. He/she is responsible for establishing/executing current sampling methods at specialized labs externally, communicating external lab performance to ClinOps and ClinMI and reporting relevant project status to the Clinical Team.
• You are responsible for the development and implementation of advanced sampling methods
and procedures in clinical studies to be performed by hospital site staff. You craft Lab Manual
and Training Material for clinical trials together with the biomarker scientists and/or external
suppliers, as appropriate.
• For methods and procedures that are being improved, you will drive the continuous updating of
the Lab Manual and other auxiliary material, such as Sample Data Sheets and Training Material
for the site staff.
• For commercially available sampling and processing methodologies, you are responsible for any
adjustments needed in the existing Lab Manual in order to accommodate our needs for
implementation in our clinical studies.
• You follow up with external suppliers that develop new sampling methods and procedures and
ensure they (and the required lab infrastructure, if applicable) ultimately meet the requirements
of the company (and regulatory authorities). This implies that you may interact with internal quality experts.
• You follow up on the performance of external suppliers (e.g. timely delivery of high quality data
and data reports) that support new procedures to be piloted and implemented in clinical studies.
• You give directions to the local or central lab on the composition of the translational sampling
kits for new procedures
• You provide input to budget forecast related to novel sampling methods and procedures in
clinical studies, as requested.
• You interact closely with Biomarker scientists and the Clinical Operation Teams (i.e. Clinical
Research Managers and/or Global Trial Leaders) to ensure alignment of operational procedures
(i.e. Lab Manuals) for samples and data flows that are fit-for-purpose.
• You give input to site selection requirements related to novel sampling methods/procedures
(infrastructure, staff training).
• You support the Biomarker scientists and Translational Sample Operations Lead on presentation of new sampling methods and procedures at Site Initiation Visits (SIVs), Site/Monitor Trainings and Investigator Meetings. You focus on the operational aspects of the sampling procedures at the training/meetings.
• Master or Ph.D. in Science with a minimum of 6 years of relevant professional experience
• Professional Experience:
– Hands-on research experience with biology lab methodologies for at least 3 years.
– Practical experience in managing human samples for at least 3 years
– Practical experience in management and conduct of clinical studies is a strong plus
Experience and Knowledge:
• Experience in management of external suppliers of laboratory services is a must.
• Exposure to translational research is important. Familiarity with clinical development of assets
related to immunology is valued.
• Knowledgeable in ICH-GCP and GCLP is required. Familiar with regulatory regulations / guidelines related to clinical validation of new biomarker methodologies is an important asset.
• Embracing to work in a cross-functional matrix organization
• Result-oriented, problem solving, meticulous, attention to details and sense of urgency
• Demonstrated ability to lead multiple assignments concurrently and to prioritize tasks effectively
• Proven ability to handle complex projects and overcome delays and obstacles
• Flexible and adaptable to meet business needs
• Proven ability to communicate to stakeholders
• Proficient in written and spoken English.
Willingness and ability to travel up to 15% of the time and to adjust working hours to accommodate different time zones and facilitate transatlantic collaborations (Asia, US, …), as needed