Senior Clinical Research Specialist (Clinical Scientist) - Onsite
About The Position
At Medtronic, the Neuroscience portfolio is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. The Neurovascular operating unit specifically advances treatment of stroke, brain aneurysms, and vascular disorders through innovative endovascular technologies. This critical position will lead clinical science and writing activities for new product development programs, design clinical strategies for regulatory approvals and market access for Neurovascular (NV) products, and manage the evidence life cycle for the NV portfolio. Medtronic emphasizes putting patients first and fostering a culture of professional growth and cross-functional collaboration through in-person exchanges, with a minimum of 4 days a week onsite.
Requirements
- Baccalaureate degree
- Minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
- Regular employees are those who are not temporary, such as interns.
- Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.
- U.S. work authorization is required for roles below the Principal level.
Nice To Haves
- Clinical Sciences in Medical Devices (especially Neurovascular or other vascular devices)
- Experience with clinical trials in Medical Devices
- Experience working with new product development teams
- A self-starter
Responsibilities
- Driving and overseeing assigned clinical strategy initiatives, working closely with Clinical Operations and the Biostatistics lead for assigned clinical trial(s) to ensure overall program success.
- Reviewing ongoing study progress and leading certain aspects of data-readiness workstreams within assigned clinical trial(s).
- Setting a 3-5 year vision and strategy for comprehensive clinical evidence strategies to position the overall portfolio for long-term success.
- Acting as a strategic thought partner within the assigned therapy franchise, collaborating with leaders in Clinical Research, Regulatory, R&D, Quality, and Marketing to develop high-quality, efficient, and innovative clinical programs.
- Assisting/leading steering committee meetings/physician advisory boards, and discussion forums to understand the evolving therapeutic space and gather input for clinical development plans.
- Leading and mobilizing the creation of clinical documents, including clinical research protocols, clinical study reports, clinical evaluation reports, and clinical marketing materials.
- Establishing and monitoring high-performance standards and metrics for the assigned portfolio.
- Reviewing and providing clinical feedback on assigned External Research Projects.
- Partnering with the Quality and Compliance Office to identify and mitigate quality and compliance risks.
- Collaborating with cross-functional teams, including marketing, sales, clinical, R&D, HE&R, Quality, Compliance, and Regulatory.
- Ensuring seamless interaction and knowledge transfer with international colleagues.
- Managing physician faculty and developing key relationships with Key Opinion Leaders (KOLs).
- Providing guidance to ensure all necessary clinical sciences activities comply with governmental and Medtronic quality standards, including ACCME, AdvaMed, ISO 9001, FDA regulations, and QSR(GMP) standards.
- Developing and cultivating strong relationships with key academic institutions, hospitals, scientific societies, and associations to facilitate evidence generation and KOL development.
- Overseeing the implementation of policies and procedures.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
