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Study Director - Senior Scientist

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Research & Development
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190005ZJ Requisition #
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Careers that Change Lives:
Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. 
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

The Senior Scientist acts as a Preclinical Study Director.  The responsibilities of the Study Director include: managing preclinical animal research studies that evaluate the safety and efficacy of medical products from Medtronic businesses; ensuring compliance to all applicable regulations in the execution of these studies; applying scientific, clinical, and/or engineering expertise to facilitate success of these projects; and contributing to evolving business systems and practices. 
A Day in the Life:
Preclinical Study/Project Management
• Manages all preclinical study activities within and outside of PRL; ensures the availability of the proper devices and equipment to successfully conduct the study, to control test devices to insure integrity; determines study schedules; and determines study objectives; ensures all aspect of the data package meet protocol requirements and expected scientific practices; all with input from the project team. 
• Leads a multidisciplinary team in the development, conduct and completion of Preclinical studies. This team is made up of numerous functions, including: quality assurance, surgical and veterinary support, animal care, clinical chemistry, pathology, project managers, engineers, and researchers.
• Partners with other scientists, researchers and engineers in the development of study designs, protocols, and final reports; independently manages studies of significant complexity (e.g. disease states, extensive data collection); contributes to overall preclinical strategy for collaborative sponsor groups 

Regulations
• The study director serves as the single point of study control and is ultimately responsible for the compliance of the study to Good Laboratory Practices, the Animal Welfare Act, and all other applicable regulations.
• Interfaces with quality assurance, regulatory committees (e.g. IACUC), and Regulatory Affairs regarding requirements and results of the study.
• Reviews Preclinical study data intended for regulatory submissions for compliance to Good Laboratories Practices.
• Establishes department and facility standards for regulatory compliance.  

Core Expertise
• Applies core scientific and/or clinical expertise that supports the product plans and research objectives of the businesses he or she supports.   
• Researches and develops appropriate animal models that will meet the needs of the studies and research goals.  Develops surgical and disease state animal models.  Applies scientific and/or clinical expertise to act as a primary expert on therapies and/or disease states within and/or outside PRL.  
• Contributes to Medtronic’s body of scientific knowledge by authoring/coauthoring and/or presenting scientifically unique findings to either a Medtronic audience or the medical and scientific community at-large.

Business
• Meets department requirements for billing.
• Assists in planning of budget and study/project schedule in meeting group business goals.
• Assists in business operations and improvements. 
• Contributes to business practices, processes and/or information systems of the department and the facility.
• Must be available to work variable hours and weekends to support business needs.  Due to the nature of the work required by this position, weekend and evening coverage may be required. 
• Ability to travel up to 20%, including international travel, for training, classes, and other departmental business, as needed.

Good Laboratory Practice
Employees must conform to the SOP’s and documentation that applies to their work areas.  This includes proper documentation techniques, updating the SOP’s, training on the SOP’s and knowledge of the GLP regulations that apply to their area.

Environmental Health and Safety
Medtronic is committed to a safe, healthy and environmentally conscious workplace that is in compliance with all applicable laws and regulations. All employees are expected to develop a pro-active, cooperative attitude toward issues of health, safety and the environment. Participation in the PRL EHS program through EHS suggestions, work procedure EHS analysis at SOP reviews and EHS committee membership is the responsibility of every employee. In accordance with the Medtronic EHS Infrastructure and Responsibilities Policy, employees must:
Understand and follow EHS policies and procedures
Actively participate in EHS programs and training
Provide suggestions and to continuously improve EHS programs

Responsibilities may include the following and other duties may be assigned.

  • Responsible for the initiation, design, development, execution, and implementation of scientific research projects.
  • Investigates the feasibility of applying scientific principles and concepts to potential inventions and products.
  • Plans and executes laboratory research.
  • Maintains substantial knowledge of state-of-the art principles and theories and may contribute to scientific literature and conferences.
  • May participate in development of patent applications.
  • May coordinate interdepartmental activities and research efforts.
Required:
•BS degree in a scientific or Technical discipline such as engineering, or biological sciences

•4-5+ years of experience directly supporting research or similar experience in a medical/scientific area.
• Demonstrated ability to effectively lead a cross-functional team.
• Advanced written and oral communications skills.
• Able to manage multiple tasks.
• Proficient knowledge of medical terminology and scientific principles.
• Expertise with GLP and regulatory compliance guidelines.
• Good problem-solving skills.
• Ability to work independently
Nice to Have:
MS degree or a Ph.D./DVM

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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