An Oncology Biomarker Scientist is required to join a fantastic Biotechnology company who specialise in providing solutions in biomarkers and bioanalytics for Biotechnology clients. The Oncology Biomarker Scientist will be a key member of the team that will be responsible for ensuring strategic operational input into clinical laboratory testing of human biological specimens and the efficient operational deployment of such clinical laboratory testing at the program level (including biomarkers, central safety testing and clinical bioanalysis for pharmacokinetic assessment). This role operates within a matrix environment in early clinical development, interfacing with multiple stakeholders (i.e., Biomarker Leaders, scientific/technical experts, clinical sciences/operational experts, CROs), and requires the candidate to effectively communicate across multiple disciplines on behalf of a major long-term client.
The role is available as an initial 12-month fixed term contract with a possibility of being made permanent. The role is also part time and will approximately consist of 20 hours a week. On offer is an extremely competitive salaryand benefits package which can be disclosed over the phone.
The Oncology Biomarker Scientist will have accountability and responsibility for the timely provision of deliverables and adherence to strict project deadlines. The conducted work will be carried out and documented in accordance with current regulatory guidance’s applicable to the activities.
In addition, the candidate will use your expertise and knowledge to contribute to the ongoing development and provision of products and services as appropriate.
Key responsibilities for the Oncology Biomarker Scientist include:
- Leveraging and integrating information with scientific rigor
- Ensure successful implementation of the biomarker strategy in the clinic.
- Identify pharmacodynamic biomarkers to inform dose selection.
- Demonstrate proof of mechanism / proof of concept in the context of the disease pathophysiology and contribute to the understanding of response prediction/resistance.
- Develop and manage biomarker data generation plans/strategies in the clinic and/or tumour-bearing non-human primate models (i.e., project planning, implementation, risk assessment/mitigation, quality system and budget compliance, 3rd party vendor management (tissue-based only), etc).
- Instil scientific rigor by ensuring biomarker data “completeness” and accurate data analysis/integration in the context of the program biomarker and/or reverse-translation strategy.
- Responsible for the authoring of biomarker implementation sections in relevant clinic study or project specific documentation (i.e., clinical protocols, SOPs, lab manuals, informed consent, IB, CSRs, eAP, SOW, FFS document, etc.)
- Drive and manage the Biomarker Matrix Team in alignment with the biomarker strategy and biomarker leaders. Provide input to the design of clinical translational, biomarker strategies, and/or pre-clinical experiments/collaborations.
- Represent biomarker function in study management teams and/or internal/external functional expert teams. Present scientific data at key internal departmental and/or external scientific meetings.
- Lead scientific/technical expert support for internal tissue-based biomarker platforms and/or cross-functional biomarker initiatives. May serve as EBDO rep on cross-portfolio initiatives.