Clinical Specialist

Integrated Resources, Inc ( IRI ); Bothell (WA); Hybrid; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Clinical Development Scientist to lead innovative clinical initiatives in the Ultrasound sector. This role involves developing clinical and economic evidence to support product development and lifecycle management. The ideal candidate will have over 7 years of experience in clinical research, a strong scientific background, and the ability to collaborate across functions. Join a dynamic team focused on driving transformation in medical equipment manufacturing and making a significant impact in the field.

Qualifications

• 7+ years of experience in clinical research and development.
• Expertise in scientific study design and AI algorithm validation.

Responsibilities

• Provide strategic guidance for clinical and economic evidence.
• Ensure quality and timeliness of clinical programs and trials.

Skills

Clinical Research

Scientific Study Design

AI Algorithm Validation

Biostatistics

Regulatory Filings

Cross-Functional Collaboration

Education

MD or PhD

Tools

Clinical Trial Design

Data Networks

Job description

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Clinical Development Scientist

DURATION - 11 months

Hybrid (open for MA and MN)

The Ultrasound, Senior Clinical Development Scientist will be responsible for developing, generating, and disseminating clinical and economic evidence to ensure innovation and transformation with best-in-class clinical evidence.

Your role

• Provide strategic guidance for clinical and economic evidence related to the end-to-end (E2E) development process from ideation through post-market for Ultrasound products. Collaborate with internal and external stakeholders to develop and lead clinical initiatives, including non-clinical and clinical strategies for new product development and product lifecycle management.
• Ensure quality and timeliness of clinical programs and trials to support regulatory requirements; be agile during design, execution, and interpretation of trial data.
• Work with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations; support claims, reimbursement, health economic outcomes, and market access. Prepare and interpret evidence such as CSRs, CERs, abstracts, peer-reviewed manuscripts. Lead or support discussions with regulatory bodies, including clinical investigations and review processes for marketing authorization and line extensions.

You are the right fit if:

• You have 7+ years of experience in clinical research/development/RWE, with expertise in scientific study design, AI algorithm validation, and a strong scientific background.
• You possess knowledge of clinical trial design, registries, quality initiatives, data networks, biostatistics, GCP, FDA regulations, EU-MDR, and product development for medical devices. Skilled in writing clinical documents like study reports, regulatory filings, investigator brochures, and scientific publications.
• You have a medical or scientific degree (MD or PhD). You can perform physical, cognitive, and environmental job requirements with or without accommodations.
• You are self-directed, agile, and work effectively in purposeful environments. You can collaborate cross-functionally, influence decisions, and communicate statistical results clearly.

Interview tips

Show enthusiasm, initiative, and motivation. Demonstrate interest and a positive attitude to stand out.

Additional details

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Research
• Industry: Medical Equipment Manufacturing