General Electric Segment Research Manager in Wauwatosa, Wisconsin
This role is responsible for the development & execution of the research strategy & portfolio for a segment within the Clinical Care Solutions businesses by understanding the business needs, marketing strategy & associated unmet clinical needs through interaction with external research collaborators & partnering with leaders of the segment P&L. This role requires technical & clinical knowledge, project mgt, clinical research & trial mgt experience, leadership & business planning skills.
Duties include (but are not limited to):
Partner with the leaders of the segment business (Chief Engineer, Business GM, Program Managers, Product Managers, and Marketing Managers), Regulatory Affairs, Legal/Compliance, the Global Research Organization, academic institutions, and GE Global Research to direct and manage research for the MS business, helping GE and academic research collaborators meet mutual objectives.
Lead FDA and other regulatory agency required studies to register new products as needed for the business
Analyze and understand scientific developments related to the segment product line through participation in MABs, scientific conferences, scientific/medical training sessions, and strategic partner meetings
Create product strategic research needs linking with business planning sessions, and utilizing feedback from product development team
Work with Technology, Marketing, Medical Affairs, and Regulatory Affairs to determine product regulatory claims strategy and the associated research required
Participate in NPI project teams to facilitate product releases through clinical and non-clinical evidence generation
Lead prioritization and selection of Investigator Sponsored Research proposals relating to segment products
Work with research operations team to define and execute operations metrics requirements
Directly manage technology research, and facilitate research execution through handoff of clinical research projects internal and external contract research organizations while maintaining oversight for research results
Complete study documentation and ensure successful handoff of execution of clinical studies to the research operations teams
Assess research deliverables obtained and ensure transfer of results to end users in the business and regional stakeholders
-Serve as a leader within the Clinical Care Solutions research team and Global research organization
BS in Physics, Chemistry, Biology, or appropriate Engineering/Science discipline or related area
8+ years of related research & development experience
Excellent communication and interpersonal skills
Demonstrated ability to make independent decisions and manage conflicting priorities in a fast-paced environment. Must be responsive and willing to take ownership of issues and drive resolution.
Significant experience research related procedures, work instructions, workflows, and associated processes
Experience working with IRBs / Ethics Committees and regulatory agencies
Team player able to work closely with a global team and open to sharing information and best practices with the team
Experience in Medical Device industry with firm understanding of working in a regulated environment
Clinical, scientific, and technical competence related to the research at GE
Ability to manage research budgets, resources and timelines
Experience in working directly with academic researchers
Ability and willingness to travel
M.S. or Ph.D. in engineering, science, or a related discipline
Demonstrated GE leadership values
Previous GE experience
GCP training and experience in clinical trials research
Good working knowledge of CFR (Code of Federal Regulations) and ISO requirements
Demonstrated strategic planner and thinker with ability to drive change across the segment products
Self-starter, energizing, results oriented, and able to multi-task
Clear thinking / problem solving: successfully led cross-functional projects/process improvement within operations function involving process improvement; able to quickly grasp new ideas·
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Locations: Finland, United States; Wisconsin; Wauwatosa, Waukesha, Milwaukee
GE will only employ those who are legally authorized to work in the United States for this opening.