Prin. Scientist - Santa Rosa
|Nombre del Puesto:||Prin. Scientist|
|Fecha de Publicación:||17/07/2017|
Executes and/or supports pre-clinical research activities to provide solutions to CSH R&D programs. Serves as pre-clinical liaison for CSH R&D projects programs. Plans, recommends, and executes pre-clinical studies and acts as a Sponsor or a Study Director in accordance to program needs. Serves as scientific technical expert for CSH R&D. Serves as the principal interface for external CROs or internal Medtronic labs performing work for CSH R&D programs. Presents data and interpretations to core teams, senior management, engineers and the scientific community through reports, conferences, and publications. Drives quality and continuous improvement to deliver excellence in processes, services and products.
Serves as a Study Sponsor or a Study Director in accordance to program needs.
When acting as a Sponsor: Reviews preclinical protocols and reports, develops and communicates timelines, attends and assists with all implants, monitors, and necropsies, assists with device management and preparation, and provides scientific interpretations of data.
Collaborates with and provides pre-clinical solutions to CSH R&D on the development of implantable cardiac valves and other valve therapies.
Identifies, evaluates and coordinates interactions with contract laboratories
Maintains familiarity with animal models, assists in model development for new applications/device and/or drug evaluations as needed.
Recognizes the difference in anatomy and physiology between large animal models and humans, develops appropriate screening criteria to identify the best candidates for in vivo animal studies for implantation with devices designed for human anatomy.
Collaborates to establish project timelines, monitors and reports progress against establishes schedule milestones
Compiles and presents data to for CSH R&D core teams, non-R&D functions and senior leadership
Provides technical advice and guidance to employees in the Life Sciences Laboratories
When acting as a Study Director: Executes study planning, generates study protocols and final reports, coordinates, attends, and monitors preclinical activities, device treatment, data collection, and PI reports. Evaluates and analyzes preclinical data; assists in identifying, clarifying and communicating issues at a senior staff level and recommend solutions.
Maintains familiarity with internal and competitor products, industry and regulatory standards, preclinical disciplines, and current and future scientific trends, including associated literature.
Where appropriate, follows the GLP regulations, 21CFR Part 58 and other applicable guidelines/regulations.
Maintains applicable technical skills and training. Assists and advises project teams in proper planning and study design of GLP and non-GLP studies to meet desired project endpoints. Communicates effectively with the project team, manager and Testing Facility Management on the progress of all project studies, and as necessary with project senior leadership.
Satisfies all Medtronic and preclinical specific training requirements. Continues ongoing preclinical training in appropriate fields which may include, but is not limited to histology, bioanalytical chemistry, implantation techniques, cath-lab skills and model development.
Mentors and trains preclinical peers. This includes proper planning and study design, execution of different types of studies, model development, as well as education on differing areas of expertise.
Peer review of study related data to ensure accuracy or clarity, as needed.
Involved in discussions, study design, and decision-making around regulatory requirements for animal studies (GLP and non-GLP).
Prepares or participates in the preparation of regulatory submissions and documentation, including technical reports, summaries, IDE and PMA submissions.
MS in animal sciences, physiology or bioengineering with preclinical experience.
7+ years of relevant experience.
Demonstrated success in working in a
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