Clinical Affairs Scientist

We are searching for an experienced Clinical Affairs Scientist (CAS) to work within the medical diagnostic field as a key member of the Organization of Chief Medical Officer (OCMO) Global Clinical Affairs team. The CAS will support clinical evidence generation in conjunction with cross-functional teams as part of the co-development process of companion diagnostics in oncology.

Responsibilities

• Provide thought leadership on key relevant clinical topics to support strategy development and execution.
• Generate content to support external validation studies, including study design and authoring of study protocols and reports.
• Contribute to cutoff/cutpoint determination studies, 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 activities, 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 the submission process, 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 effective, efficient, and 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, as well as 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

This is a full-time position 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 ranges are determined by role, level, and location, with individual pay based on job-related skills, experience, and relevant education or training.