Clinical Affairs Scientist

We are searching for an experienced Clinical Affairs Scientist (CAS) to join the Organization of Chief Medical Officer (OCMO) Global Clinical Affairs team in the medical diagnostic field. This role supports clinical evidence generation as part of the co-development process of companion diagnostics in oncology, working with cross-functional teams.

Responsibilities

• Provide thought leadership on key clinical topics to support strategy development and execution.
• Generate content for external validation studies, including study design and authoring of protocols and reports.
• Contribute to cutoff/cutpoint determination, method comparison, bridging, and analytical concordance studies.
• Design and develop databases, Electronic Data Capture (EDC) systems, and case report forms.
• Contribute to risk analyses, study quality control, and in-stream data monitoring in clinical trials.
• Ensure scientific validity of reported results, including statistical analysis, tabulation, and presentation of data.
• Collaborate with regulatory and development teams during submission processes, including authoring clinical performance information and documentation such as Instructions for Use (IFU).
• Provide clinical and scientific oversight of local marketing and commercial materials.
• Ensure compliant Clinical Affairs processes, including preparing, revising, and maintaining standard operating procedures for clinical studies.
• Serve as the clinical science subject matter expert in cross-functional internal meetings and external meetings with pharmaceutical partners and regulatory bodies.
• Author manuscripts, abstracts, whitepapers, and prepare oral/poster presentations.
• Support audits and inspections as a clinical subject matter expert.

Requirements

• Master's degree or advanced degree (e.g., Ph.D., Pharm. D., M.D.) in pharmaceutical, medical, or relevant biomedical science fields. Advanced degree preferred.
• 4+ years of experience in IVD product development, clinical research, medical writing, and/or clinical science in the medical device and/or pharmaceutical industry.
• Familiarity with clinical trial design, conduct, and oversight, including biostatistics and Good Clinical Practice.
• Ability to interpret regulatory standards, guidance, and laws.
• Strong scientific, medical writing, and presentation skills.
• Exceptional ability to manage multiple projects in a fast-paced environment with changing priorities.
• Must be able to work independently, make decisions, understand complex scientific and clinical data, and take initiative to lead projects.
• Experience working with external partners and/or regulatory bodies, including the FDA.
• Knowledge in oncology, immunology, and/or pathology preferred.

Schedule

Full-time weekly schedule with the option to work remotely.

Pay

The full-time equivalent pay range for this position is $105,280.00 - $197,400.00 per year, plus eligibility for bonus, stock, and benefits. Pay is determined by role, level, location, and additional factors such as job-related skills, experience, and relevant education or training.