Principal Clinical Research Specialist

Medtronic

Clinical Research Spec at Medtronic, driving healthcare innovation through strategic evidence generation and product development. Collaborating across teams to influence clinical insights and decisions.

Posted 5/18/2026full-timeLafayette • Colorado, Minnesota • 🇺🇸 United StatesSeniorLead💰 $144,800 - $217,200 per yearWebsite

About the role

Key responsibilities & impact

Serve as the Clinical Research representative on New Product Development (NPD) core teams, acting as the primary clinical voice throughout the product lifecycle—from concept through post-market evaluation
Develop and lead clinical evidence strategies aligned to regulatory, medical, and commercial objectives, including identification of evidence gaps necessary to support safety, performance, and claims
Critically evaluate and synthesize clinical literature and competitive evidence landscapes to inform product development decisions, clinical positioning, and differentiation strategy
Lead and influence clinical study design, including protocol development, endpoint selection, and overall evidence generation approach to support intended use and global market needs
Provide clinical oversight, review, and approval of product claims to ensure alignment with scientific evidence, regulatory requirements, and reimbursement strategies
Partner cross-functionally (R&D, Regulatory, Marketing, Medical Affairs, Quality) to integrate clinical insights into product requirements, risk management, and benefit-risk assessments
Drive development of key clinical deliverables, including Clinical Evaluation Plans/Reports, Clinical Study Reports, and other documentation supporting regulatory submissions and product commercialization
Synthesize clinical data to support regulatory approval, evidence dissemination, and lifecycle management activities
Identify and proactively manage clinical and patient-related risks early in development, contributing to mitigation strategies and overall product safety profile
Influence Voice of Customer (VoC) translation and ensure clinical insights are reflected in product design, usability, and intended use

Requirements

What you’ll need

Bachelor’s degree required
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
Advanced degree (MS, PhD, MD, or equivalent) in a scientific, clinical, or healthcare-related field
Experience serving as a Clinical Core Team member or clinical lead on new product development (NPD) or product lifecycle teams
Demonstrated experience developing clinical evidence strategies aligned to regulatory, commercial, and reimbursement objectives
Strong familiarity with global regulatory requirements (e.g., FDA, EU MDR) and their impact on clinical evidence, claims, and product development
Experience supporting or leading clinical claims development, review, and approval processes
Experience with Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and post-market clinical follow-up (PMCF) activities
Proven ability to translate clinical literature and data into actionable insights that influence product design, labeling, and business strategy
Experience partnering cross-functionally with teams in a matrixed environment
Track record of contributing to regulatory submissions, publications, or scientific communications
Experience in clinical study design and execution across various methodologies (e.g., feasibility, observational, randomized controlled trials), including endpoint selection, evidence generation planning, including oversight of timelines, study operations, and cross-functional coordination
Familiarity with health economics and outcomes research (HEOR) and its application to reimbursement, value messaging, and market access strategies
Strong communication and influencing skills, with the ability to effectively represent clinical perspectives to both technical and non-technical stakeholders
Experience mentoring or leading extended clinical team members or serving as a subject matter expert within a therapeutic area.
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.

Benefits

Comp & perks

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)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical evidence strategiesclinical study designprotocol developmentendpoint selectionClinical Evaluation PlansClinical Evaluation Reportspost-market clinical follow-upregulatory submissionshealth economicsoutcomes research

Soft Skills

strong communication skillsinfluencing skillscross-functional collaborationmentoringleadershipanalytical thinkingproblem-solvingstakeholder engagementstrategic thinkingrisk management

Certifications

Bachelor's degreeadvanced degree (MS, PhD, MD)