Clinical Affairs Scientist (Oncology)

Location: US-CA-Carpinteria; remote work option available

Salary: $105,280–$197,400 per year, plus eligibility for bonus, stock, and benefits.

Company

hirify.global develops technologies and solutions for medical diagnostics and related scientific applications.

What you will do

• Support clinical evidence generation and co-development of oncology companion diagnostics with cross-functional teams and pharmaceutical partners.
• Design external validation studies and author clinical study protocols, reports, manuscripts, abstracts, whitepapers, and presentations.
• Contribute to databases, Electronic Data Capture systems, case report forms, cutoff and cutpoint studies, method comparisons, bridging, and analytical concordance studies.
• Support clinical trial risk analyses, quality control, data monitoring, statistical analysis, tabulation, and presentation of results.
• Collaborate on regulatory submissions, clinical performance documentation, Instructions for Use, and compliant clinical affairs processes.
• Provide clinical science expertise to internal meetings, pharmaceutical partners, regulatory bodies, audits, and inspections.

Requirements

• Master’s degree or advanced degree in pharmaceutical, medical, or relevant biomedical sciences.
• 4+ years of experience in IVD product development, clinical research, medical writing, or clinical science within the medical device or pharmaceutical industry.
• Knowledge of clinical trial design, conduct, oversight, biostatistics, Good Clinical Practice, and regulatory standards.
• Strong scientific, medical writing, presentation, project management, and independent decision-making skills.
• Experience working with external partners or regulatory bodies, including the FDA.
• Ability to manage multiple projects, interpret complex clinical data, and lead assignments in a changing environment.

Nice to have

• Advanced degree such as a Ph.D., Pharm.D., or M.D.
• Knowledge of oncology, immunology, or pathology.

Culture & Benefits

• Full-time schedule with no stated end date.
• Remote work option.
• Eligibility for bonus, stock, and benefits.
• Day shift with no travel required.
• Inclusive, equal-opportunity work environment.