Senior Clinical Scientist

PathAI; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

PathAI is seeking a Senior Clinical Scientist to enhance IVD device development through strategic clinical oversight and collaboration across multidisciplinary teams. The candidate will contribute significantly to clinical trials and regulatory submissions, demanding strong scientific expertise and communication skills. This role embodies a commitment to improving patient outcomes via innovative diagnostic technologies.

Qualifications

• Advanced degree in biomedical sciences, pathology, or clinical research.
• 3+ years of experience in clinical development or regulatory affairs.
• Familiarity with GCP/GCLP guidelines.

Responsibilities

• Develop and implement clinical development strategies.
• Lead clinical studies in compliance with regulations.
• Communicate findings to stakeholders effectively.

Skills

Regulatory Submission Processes

Clinical Trial Design

Analytical Skills

Communication

Collaboration

Education

PhD

MD

PharmD

Job description

PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.

Where You Fit

PathAI is seeking a Senior Clinical Scientist to play a key role in driving our in vitro diagnostic (IVD) device projects and validation strategies across all business units, from a clinical science standpoint. This individual will be responsible for activities across the clinical development services and IVD development lifecycle, including development of clinical plans and study protocols for validation studies, providing scientific oversight during clinical trials, analyzing study results, and contributing to regulatory submissions. The ideal candidate will have strong scientific and medical knowledge, experience with regulated IVD device validation studies, excellent communication and writing skills, and the ability to collaborate across multidisciplinary teams.

What You’ll Do

• Clinical Strategy & Execution
  • Collaborate with the clinical, product, biostats and regulatory teams to develop and implement clinical development strategies for medical device submissions and fit-for-purpose validation studies.
  • Design and execute method comparison studies to enhance the menu of AI-based digital pathology products.
• Study Design & Documentation
  • Develop and author clinical protocols, study reports, and regulatory submission documents in compliance with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) guidelines.
  • Lead clinical science components of Clinical Development Services (CDS) and IVD programs to deliver clinical studies on time, in budget & compliance to regulations, policies & SOPs, working with cross functional teams (Pathology, Quality, Regulatory, Product Development, Clinical Operations, HEMA, Medical Affairs, Biostatistics, Data Management))
• Data Analysis & Interpretation
  • Work closely with PathAI’s statistical team to develop and execute statistical analysis plans for clinical studies.
  • Support data review and interpretation to ensure clinical relevance and regulatory compliance.
  • Support the clear, effective communication of scientific findings, both written and verbally, to internal stakeholders, external collaborators, clients and regulatory bodies.
• Cross-functional Collaboration
  • Partner with pathologists, regulatory, quality, and product teams to design and execute robust clinical studies demonstrating the safety, efficacy, and performance of PathAI products.
  • Provide clinical input to cross-functional teams to ensure alignment with strategic business objectives.
• External stakeholder and partner engagement
• Build and maintain strong working relationships with external partners including pharma clinical science and regulatory functions in support of Class II and Class III co-development programs.
• Engage and interact with global regulators including FDA and EMEA in partnership with Regulatory to align on validation study design, intended use statements and overall clinical validation strategy and approach.

What You Bring

• Advanced degree (PhD, MD, PharmD, or equivalent) in a relevant scientific discipline such as biomedical sciences, pathology, or clinical research.
• 3+ years of experience in clinical development, clinical trials, or regulatory affairs within diagnostics, medical devices, or biotech/pharmaceutical industries.
• Experience with regulated IVD development including Class II and Class III devices.
• Experience in digital pathology, AI-powered diagnostics, or computational pathology is a preferred. Experience with pharmaceutical drug and/or companion diagnostic device development is a plus.
• Knowledge of clinical trial design, regulatory submission processes, and GCP/GCLP guidelines.
• Strong analytical skills and ability to work with biostatisticians to interpret clinical data.
• Excellent written and verbal communication skills, with the ability to convey complex scientific concepts to diverse audiences.
• Ability to work effectively in a dynamic, fast-paced, collaborative environment.

We Want To Hear From You

At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for.
PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.

About the company

PathAI is evolving pathology using machine learning and deep learning techniques to drive faster more accurate diagnosis of disease.

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