Translational Sampling Manager
For one of the world leading pharma companies in the Antwerp region, we are looking for a Translational Sampling Manager whose key role is to introduce (new) sampling methods and (new) sample analysis platforms (to assess novel biomarkers) into clinical studies. If interested, please apply on www.noveallashealthcare.com.
Investigating the liver in search for specific biomarkers as sensors for therapy success in chronic Hepatitis B infection, is instrumental to define the activity/impact of a therapy on specific cells. In parallel, because of the rather invasive character of the collection of a liver sample, it is key to look for parameters that correlate with the liver biomarkers but are more easily accessible.
The Translational Sampling Manager (TSM) has a key role in introducing (new) sampling methods and (new) sample analysis platforms (to assess novel biomarkers) into clinical studies in which the company’s portfolio of new therapies for chronic hepatitis B patients is developed. The TSM will use his/her experience and skillset in developing robust laboratory protocols for biological sampling methods and subsequent sample processing for interventional trials, with a focus on the applicability and learnability in a clinical study site setting.
- Define and establish the logistical chain from sample to centralized data generation to be readily implemented into early and full development clinical trials.
- Discuss, create and provide clear User protocols, instruction manuals and tailored operational learning templates & educational training material for the sites to consistently adopt the new sampling platforms. Such protocol/manuals are created in solid concertation with development team members responsible for the application of established biomarkers and sampling procedures
- Provide support for scientific educational communications towards internal development teams and external investigators.
- Support the upgrade of performance and robustness of new platforms from research grade to an industrial application grade.
- Support the validation of new methods and platforms that generate data representing secondary or primary endpoints in a clinical study, in such a way that these methods and platforms meet the requirements of Janssen, of the Pharma industry in general and of the regulatory authorities.
Education & Experience:
- PhD in Life Sciences
- Hands-on work and organisational expertise in a life science laboratory
- Minimum of 5 years of
- clinical trial experience in ED environment in the pharmaceutical industry or CRO
- working in a matrix organization, including in an international and virtual setting
- Strong expertise in vendor management
- Experience in working in a cell culture lab is an asset
- Experience in (clinically) validating Assays that fulfil pharma’s and regulatory authority’s requirements is a strong asset
- ClinicalOperational knowledge in ED is a must
- ClinicalOperational knowledge in FD is an asset
- Experience with startup vendors is an asset
- Preexisting knowledge about cell sorting, sequencing and histochemistry techniques is an asset
Competencies & Skills:
- Strong problemsolving skills while maintaining high standards of quality, ethics and compliance
- Ability and flexibility to prioritize and to work with short timeframes for deliverables
- Good communication skills in setting clear objectives, persuading others to accept new approaches and gaining alignment on divergent issues
- Demonstrated expertise in working crossculturally