Senior Clinical Scientist

PathAI; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Scientist to enhance in vitro diagnostic projects through innovative strategies and collaboration. This role involves developing clinical science plans, executing validation studies, and ensuring compliance with regulatory standards. Ideal candidates will possess a strong scientific background, experience in clinical trials, and excellent communication skills. Join a dedicated team focused on improving patient outcomes with cutting-edge AI technology and make a significant impact in the field of pathology. If you are passionate about advancing medical science and thrive in a collaborative environment, this opportunity is perfect for you.

Qualifications

• Advanced degree in biomedical sciences or clinical research required.
• 3+ years in clinical development or regulatory affairs preferred.

Responsibilities

• Develop clinical science plans and protocols for validation studies.
• Collaborate with cross-functional teams for clinical study execution.

Skills

Clinical Development

Regulatory Affairs

Data Analysis

Communication Skills

Collaboration

Analytical Skills

Education

PhD in Biomedical Sciences

MD

PharmD

Tools

Good Clinical Practice (GCP)

Good Clinical Laboratory Practice (GCLP)

Job description

Who We Are

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, strategy and roadmaps. This individual will be responsible for activities across the IVD development lifecycle, including development of clinical science plans and clinical 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 skills, and the ability to collaborate across multidisciplinary teams.

What You’ll Do

• Clinical Strategy & Execution
  • Collaborate with the clinical science, product 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 IVD programs to deliver clinical studies on time, in budget & compliance to regulations, policies & SOPs, working with cross functional teams (Quality, Regulatory, Product Development, Clinical Development, HEMA, Medical Affairs, Biostatistics, Data management, monitor, clinical study).
• 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.
• 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 plus. Experience with pharmaceutical drug and/or companion diagnostic device development preferred.
• 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 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.