US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-Plymouth
About the role:
This is a hybrid position (in office minimum three days per week) to be located in Arden Hills, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
Your responsibilities will include:
- Serve as a preclinical expert to R&D core teams, Marketing, Regulatory or other functions in long term project objectives including Preclinical regulatory strategy and in vivo/ex vivo study design.
- Effectively communicate preclinical strategy and study design to project stakeholders.
- Independently develop preclinical in vivo/ex vivo study design based on device and technology needs.
- Participate and collaborate with POSM colleagues in vendor selection process of preclinical test sites and its management.
- Provide oversight and serves as liaison during study execution to ensure integrity, timeline, budget of the study are met and communicated to appropriate stakeholders, including multi-site studies.
- Participate in and/or lead preclinical study planning and conduct including protocol development, study execution, data analysis, interpretation, and reporting.
- May serve as a mentor to junior members of the team.
- Assist in the development of translational models as needed to meet project or corporate objectives by working closely with internal and external resources.
- Build solid relationships of trust, influence and contribute to collaboration across all functions within the preclinical department and across internal collaborator functions.
- Demonstrate a passion for learning, sharing, and discovering new information.
Required qualifications:
- Minimum bachelor’s degree in Biological Sciences or related field
- Minimum 5 years of relevant experience in Preclinical or related field
Preferred qualifications:
- Master’s degree preferred with 3 years of relevant experience
- Knowledge of GLP regulations is desirable.
- Experience with regulatory body submissions including FDA, Eu MDR, PMDA, or NMPA.
- Excellent skills in multiple computer tools including but not limited to: Word, Excel, Minitab, Power Point, Minitab or other data analysis programs.
- Excellent communication, presentation, analytical, and technical writing skills.
- Highly motivated and able to work in a semi-independent or independent manner, experienced working in a collaborative, and team-based environment.