This role represents the Biomarkers Leads on Protocol specific Clinical teams and on the Compound Development Team when needed. This role will facilitate the development and institution of biomarker plans for the evaluation of biological therapeutics in clinical development.
This position would be located in Beerse and responsible for leading the implementation of standard processes working closely with the department's Director to align efforts across small and large molecule studies.
- As a biomarker clinical team (CT) representative primary responsibility will be to implement operations specific biomarker strategies in clinical studies.
- Contribute biomarker related information to the preparation of clinical documents such as clinical study synopsis, protocols, clinical study reports, early development plans. Also contribute program and study specific biomarker plans for clinical stage gate review presentations and for other approval meetings.
- As a CT biomarker representative, working closely with the biomarker lead on the CDT, propose, identify relevant biomarker assays (internal or external) to achieve the biomarker objectives of the program.
- Work closely with CT representatives from other functional areas, such as Global Clinical Operations (GCO), clinical group, medical writers, biostatistics, data management etc.
- CT representative for the program, present biomarker plans at investigator meetings, provide training to trial managers, site monitors etc.
- Oversee and contribute information regarding biomarker sample collection and other procedures in synopsis, lab manual, vendor scope of work documents, laminated training materials and in informed consent forms for the sites.
- Evaluate and implement new assays and relevant technologies as needed. Maintain interfaces with commercial laboratories for assay development and assay transfer for implementation in clinical trials.
- Drafts & performs quality review of biomarker related reports
- Responsible for assisting and/or completing biomarker technical reports as directed.
- Responsible for supporting the Human Resources Planning (HRP) programs including management and staff development and training to meet current and future needs.
- Directs the oversight and implementation of Biomarkers strategic objectives as developed by the Biomarker Leads in clinical trials including, sample quality, timeliness, biomarker administrative needs (budget, presentations, study documents), continuous process improvement, and change management. Responsible for all sample logistics within clinical trials from study start up through final close out visit ensuring that all regulatory & organizational requirements are met.