Senior Clinical Scientist - Hybrid
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
This Senior Clinical Scientist will be a key contributor in the clinical science activities of evidence generation for regulatory approval and/or engagement with physicians and payers, including protocol development, study implementation, data analysis, and reporting of results.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Travel Expectation: 20%
Responsibilities may include the following, and other duties may be assigned.
- Support the development of clinical strategies for regulatory approvals and expanded indications of devices and/or pharmaceuticals in the chronic rhinosinusitis therapy area
- Prepare and author protocols and amendments, investigator brochures, and other relevant deliverables related to the scientific perspectives of the clinical study
- Provide scientific expertise to clinical trial managers on scientific issues related to the study conduct, and serve as a resource to address any questions or clarify issues arising during the conduct of the study
- Prepare scientific publications and conference abstracts/presentations for effective clinical evidence dissemination within the therapy field
- Build and maintain optimal relationships and effective collaborations with various internal (e.g., cross-functional team) and external parties (e.g., key opinion leaders)
- Understand the current clinical landscape and future implications for relevant indications/ patient populations, in order to help drive strategy and marketing opportunities
- Assist Data Management with data collection, review, cleaning, and safety monitoring
- Work with biostatisticians to compile and analyze the study data to draw conclusions for both internal and external presentation targeting various audiences (cross-functional team, key opinion leaders, payer, etc)
- Author clinical study reports, annual reports, clinical evaluation reports, and other clinical documents for regulatory submissions
- Conduct systematic literature reviews to support stand-alone projects, protocols, clinical evaluation reports, or other evidence-based summaries of clinical literature
Qualifications
Must-Have: Minimum Requirements
- Requires a Baccalaureate degree
- Minimum of 4 years of clinical scientist experience, or an advanced degree with a minimum of 2 years of experience.
Nice to Have
- Advanced degree (PhD or Pharm D) in life sciences, engineering, or related fields
- Direct experience with IDE and/or IND clinical study design and regulatory submission
- Working knowledge of the FDA and key international regulations (e.g., ICH/ISO) for clinical studies
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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