About the role:
The Biomarker Development department (BMD) in NIBR Translational Medicine delivers integrated biomarker plans using diverse expertise and knowledge in genetics, genomics, imaging, protein and cellular biology, human tissue research, vendor scientific monitoring, statistics, bioinformatics, digital endpoints, patient centric sampling and study coordination.
Biomarker solutions are critical in clinical development to: define the stage/subtype of the disease; predict the effect of medication; select a group of patients who would benefit most from a given therapy; and identify opportunities for development of companion diagnostics. Our scientists identify and use a wide range of biomarkers to investigate a disease, profile a compound’s mechanism of action, potency and likely side effects, select patients who may respond to therapy based on their genetic profile; and develop parallel/expanded indications for the compound.
During the BMD 2-year trainee program, you will receive training and mentorship, you will be empowered to do and learn and you will work in a diverse, multicultural, global and inclusive environment. Key learning areas include:
Key Responsibilities:
?Represent BMD on clinical trial teams; work with biomarker experts and clinical trial leaders to develop biomarker plans for implementation in clinical studies.
?Gain familiarity with innovative biomarker technologies used in clinical research.
?Develop relevant study documentation, including clinical protocol biomarker sections, lab manuals, informed consent forms and biomarker study budgets. ?Work with internal and external stakeholders to resolve issues related to biomarker samples in ongoing clinical trials.
?Acquire knowledge of potential ethical issues related to biomarker sample collection and analysis, and devise solution that satisfy both ethical concerns and study objectives. ?Learn to perform logistical and operational activities for innovative biomarkers, coordinating with clinical sites, managing and tracking material supply and sample at sites, central lab, and external service providers.
?Monitor and provide oversight of biomarkers and laboratory assays (e.g. flow cytometry, Immunoassays) at external partners (CRO).
?Lead and contribute to process improvement projects, technology evaluation operational innovation and initiatives across NIBR sites.
Essential Requirements:
?A recent graduate (advanced degree e.g. PhD, PharmD, MS) in laboratory/clinical or related fields ideally with some experience in laboratory analysis (e.g. Immunoassays, Flow cytometry, mass spec, genetics) and exposure to clinical trials (or clinical samples).
?Interest to work in clinical studies at the interface of exploratory/ fit for purpose biomarkers (with internal and external labs), and clinical trial operations.
?Drive and organize projects (details matter!) despite complexity and ambiguity, and learn and contribute to our mission of “ Right samples, right lab, right time and right quality” ?New ideas and Energy to work with very dynamic global team, multiple experts in a matrix environment, clinical sites and external CROs.