Clinical Development Scientist

AccuScan Sciences; Milpitas (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

AccuScan Sciences in Milpitas, CA seeks a Clinical Development Scientist to design, execute, and interpret clinical studies supporting molecular diagnostic products. You will work with clinical, scientific, regulatory, medical affairs, and quality teams to generate evidence for product development, submissions, reimbursement, and publications.

The ideal candidate holds a PhD/MD/PharmD or equivalent and has 3+ years in clinical development or translational oncology diagnostics, with strong

Qualifications

• PhD/MD/PharmD or equivalent in a relevant life sciences field.
• Experience in clinical development, translational research, oncology diagnostics, biotech, or pharma.
• Strong understanding of oncology trials and biomarker development.
• Excellent scientific writing and communication skills.

Responsibilities

• Contribute to development and execution of clinical strategies for oncology programs.
• Design study concepts, protocols, and statistical analysis plans with cross-functional teams.
• Manage timelines and deliverables across multiple programs in clinical development.
• Serve as scientific lead for clinical studies, aligning endpoints with product goals.
• Collaborate with biostatistics and bioinformatics to analyze results.
• Support site selection, investigator engagement, and study start-up activities.
• Review progression, enrollment metrics, data quality, and protocol compliance.
• Prepare and review study reports, abstracts, posters, manuscripts, and presentations.
• Support regulatory submissions and inspection readiness with Regulatory and Quality teams.
• Collaborate with Medical Affairs and other teams to translate evidence into product value propositions.

Skills

Clinical development

Translational research

Biomarker development

Molecular diagnostics

Scientific writing

Cross-functional collaboration

Data interpretation

Regulatory knowledge

Education

PhD, MD, PharmD or equivalent in Molecular Biology, Cancer Biology, Genetics, Genomics, Biomedical Sciences, or related field

Job description

About AccuScan Sciences

AccuScan Sciences is a biotechnology company developing whole-genome-sequencing-based liquid biopsy tests for minimal residual disease (MRD) detection and precision oncology applications. Our work sits at the intersection of genomics and oncology, with a focus on advancing diagnostic capabilities that can help inform patient care, clinical decision-making, and the development of precision medicine strategies.

As a Clinical Development Scientist, you will play a key role in the design, execution, and interpretation of clinical studies supporting the development and validation of innovative molecular diagnostic products. You will work closely with clinical, scientific, bioinformatics, regulatory, medical affairs, laboratory operations, and quality teams to generate clinical evidence that supports product development, regulatory submissions, reimbursement initiatives, and scientific publications.

Responsibilities

• Contribute to the development and execution of clinical strategies supporting oncology and molecular diagnostic programs.
• Design clinical study concepts, protocols, statistical analysis plans, and study-related documentation in collaboration with cross-functional stakeholders.
• Manage timelines and deliverables for clinical development activities across multiple programs.
• Serve as the scientific lead for clinical studies, ensuring alignment between study objectives, endpoints, and product development goals.
• Collaborate with biostatistics and bioinformatics teams to analyze, interpret, and communicate clinical study results.
• Support site selection, investigator engagement, study start-up activities, and ongoing study management.
• Review and monitor study progress, enrollment metrics, data quality, and protocol compliance.
• Author and review clinical study reports, abstracts, posters, manuscripts, and scientific presentations.
• Partner with Regulatory Affairs and Quality teams to support regulatory submissions, inspection readiness, and compliance with applicable regulations and Good Clinical Practice (GCP) standards.
• Collaborate with Medical Affairs, Business Development, and Commercial teams to translate clinical evidence into product value propositions and adoption strategies.
• Identify clinical risks, scientific gaps, and mitigation strategies throughout the product development lifecycle.
• Maintain effective communication and alignment across internal and external stakeholders, including academic collaborators, investigators, CROs, and industry partners.
• Monitor emerging scientific literature, clinical trial results, and competitive developments in oncology, MRD, and liquid biopsy technologies.

• PhD, MD, PharmD, or equivalent advanced degree in Molecular Biology, Cancer Biology, Genetics, Genomics, Biomedical Sciences, or a related field.
• 3+ years of experience in clinical development, translational research, oncology diagnostics, biotechnology, or pharmaceutical development.
• Demonstrated experience supporting clinical studies, including protocol development, study execution, data interpretation, and scientific reporting.
• Strong understanding of oncology clinical trials, biomarker development, and molecular diagnostic technologies.
• Experience collaborating with cross-functional teams including clinical operations, laboratory operations, bioinformatics, biostatistics, regulatory affairs, and quality.
• Excellent scientific writing, presentation, and communication skills.
• Eligibility to work in the United States.

Preferred

• Experience in liquid biopsy, ctDNA, MRD, next-generation sequencing (NGS), or precision oncology.
• Familiarity with CLIA/CAP laboratory environments and diagnostic assay development.
• Experience supporting regulatory submissions, clinical evidence generation, or reimbursement initiatives for molecular diagnostics.
• Track record of peer-reviewed publications, conference presentations, or scientific leadership in oncology-related programs.
• Experience working with academic investigators, cooperative groups, pharmaceutical partners, or CROs.