Medical Device Study Director/ Principal Scientist
The Principal Scientist would participate in Medical Device & Therapeutic studies in the functional role of a Study Director to conduct and oversee pre-clinical studies (acute and chronic, GLP and non-GLP, rodents, rabbits, pigs, sheep) that evaluate implantable devices (blood glucose monitors, prosthetic valves, nerve stimulators, drug-eluting implants), vascular instruments (stents, mesh, clot filters, clot retrievers, catheters), and/or dermal products for wound healing. The position requires the ability to interpret scientific data for the purpose of Sponsor reports and/or GLP reports intended for FDA submission and approval. Familiarity with imaging modalities (ultrasound, fluoroscopy) and/or surgical-technical experience in animal models is preferred as well as familiarity in animal science (anatomy-physiology). Expertise to guide investigators (Sponsors) on the approaches necessary to evaluate their device based on disease mechanisms is valuable. The candidate should be able to communicate, support, and mentor technical staff on study aspects as needed.
Principal Duties and Responsibilities
The Principal Scientist will perform the following duties and responsibilities:
Manage the conduct of preclinical Medical Device studies as Study Director under GLP conditions (GLP training will be performed on-site).
Develop and execute research studies to expand research capabilities.
Provide technical support to potential clients regarding the company research models and services.
Provide support and technical training to the organization’s research staff, including efforts to continually refine and adopt new and best practices for study purposes.
Ability to learn and expand technical skills in surgical-anesthesia support
Provide input on the scientific design (technical expertise/advice) and literature search to facilitate IACUC protocol development.
May develop new or innovative disease models or study designs to expand the company’s capabilities
May assist in the management of the activities within the group, including providing direction to junior employees, scheduling activities, and personnel development of research associates.
Perform other duties as directed by Management.
Ability to perform duties and responsibilities with minimal supervision.
Good interpersonal and communicative skills with staff and the ability to articulate scientific aspects to clients.
Masters (MS) or PhD in a field of biology, biomedical sciences, zoology, and/or veterinary science with adequate experience is required.
Degree in veterinary medicine (DVM, VMD, BVM) preferred but not required. Additional education-training in lab animal, GLP pre-clinical research is desired but not required.
Minimum 2-3 years’ experience preferred.
Other: Computer literacy in word processing, spreadsheet and database software. Ability to organize, prioritize work and meet deadlines.
Excellent oral and written communication skills. Problem solving abilities are required.