Clinical Affairs Scientist

This is a fully remote position, open to applicants in California, +4 more states.

📋 Description

• Assist in generating clinical evidence alongside cross-functional teams during the co-development of oncology companion diagnostics.

• Aid in the design and execution of clinical trial studies, regulatory applications, and scientific marketing outputs.

• Provide strategic thought leadership on pertinent clinical topics for the development and implementation of strategies.

• Create content for external validation studies, which includes study design, authoring study protocols, and writing reports.

• Contribute to the determination of cutoff/cutpoint values, method comparisons, bridging studies, and analytical concordance studies.

• Design and develop databases, Electronic Data Capture (EDC) systems, and case report forms.

• Participate in risk analyses, ensure study quality control, and monitor data in real-time during clinical trials.

• Guarantee the scientific validity of reported outcomes through statistical analysis, data tabulation, and presentation.

• Collaborate with regulatory and development teams on submissions, including clinical performance data and Instructions for Use (IFU) documentation.

• Provide clinical and scientific oversight for local marketing and commercial materials.

• Prepare, update, and maintain standard operating procedures to ensure compliant clinical study conduct.

• Act as a clinical science subject matter expert in meetings with internal teams, pharmaceutical partners, and regulatory bodies.

• Write manuscripts, abstracts, whitepapers, and prepare oral/poster presentations.

• Support audits and inspections as a clinical subject matter expert.

• Report to the Manager of Clinical Affairs Sciences; this position has no direct reports.

⛳️ Requirements

• A Master's degree or an advanced degree (e.g., Ph.D., Pharm. D., M.D.) in pharmaceutical, medical, or relevant biomedical science disciplines.

• Over 4 years of experience in IVD product development, clinical research, medical writing, and/or clinical science within the medical device and/or pharmaceutical sectors.

• Familiarity with clinical trial design, execution, and oversight, including biostatistics and Good Clinical Practice is preferred.

• Ability to interpret regulatory standards, guidelines, and laws.

• Strong skills in scientific writing, medical writing, and presentations.

• Capability to manage multiple projects in a dynamic environment with shifting priorities.

• Ability to work independently, interpret complex scientific and clinical data, and take initiative in leading projects and assignments.

• Experience collaborating with external partners and/or regulatory agencies, including the FDA.

• Knowledge in oncology, immunology, and/or pathology is preferred.

🏝️ Benefits

• Eligibility for bonuses.

• Eligibility for stock options.

• Comprehensive benefits package.

• Option to work remotely.