Initiates, monitors and conducts Study Initiation and Close Out procedures at clinical study centers; inclusive of training of study site personnel, oversight of protocol adherence, data verification of source documents and accountability of all study supplies. Must be able to troubleshoot and resolve routine study conduct issues.
The successful candidate will be responsible for the design and execution of selection and screening strategies to isolate high affinity antibodies that meet criteria such as species cross-reactivity and biological function.
Plan, conduct, analyze and report out on a broad range of user research studies, including iterative and summative usability testing (moderated and unmoderated), field studies, participatory design, expert/heuristic evaluations, and competitive assessment.
In this role, the selected candidate must have strong understanding of data structures, algorithms, and design pattern; demonstrated experience in data curation, data mining and an ability to interrogate, interpret, and visualize large and diverse, biological and toxicological datasets.
Provide technical leadership and hands-on contributions to pre-development and product development projects for Diagnostics in a team environment. This group utilizes triple-quad mass spectrometers as the detection instrument for assay development under an IVD quality system for Newborn Screening and adjacent clinical space.
Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
Independently design, execute and interpret in vivo pharmacology experiments to characterize small molecule based drug pharmacology and mechanism of action to support projects from early discovery to clinical development.
The position will perform data analysis, including the analysis of newly produced data plus integration of large amounts of external data, with a strong focus on biological interpretation and pathway / network analysis.
Act as the major individual contributor or analytical leader on multiple projects, including interacting with clients, reviewing and evaluating data, and writings analytical or bio analytical reports and protocols.
Ability to work with business partners and GBS (our global business services and solutions provider) to maintain and enhance short and long-term Business Analytics strategy and roadmap designed to anticipate, understand and respond to business priorities.
Collaboratively plan and execute in-depth analyses using techniques such as ellipsometry, DSC, TGA, FTIR, Raman, SEM, XPS, TOF-SIMS, AFM, high resolution spectroscopy and microscopy to characterize dimensions at the interface between assay chemistry and substrate materials.