Senior Clinical Scientist

Senior Clinical Scientist

Requirements

• 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.
• 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.

Responsibilities

• 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.
• 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).
• 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.
• 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.
• 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.

Preferred Qualifications

• Experience in digital pathology, AI-powered diagnostics, or computational pathology is a plus.
• Experience with pharmaceutical drug and/or companion diagnostic device development preferred.