Oncology Clinical Research Director - Hybrid

Taiho Oncology; Pleasanton (CA); Hybrid; USD 238,000 - 280,000; Full time

Job summary

Taiho Oncology in Pleasanton, CA is seeking a Director, Clinical Research Scientist to lead design, execution and reporting of oncology trials (Phase 1–3) and support medical monitoring and CRS process improvements.

You will collaborate with medical leads, data management and statisticians to prepare regulatory submissions, study documents, and presentations while ensuring TMF compliance and high-quality scientific output.

Qualifications

• At least 3 years in drug development industry in oncology and with previous exposure to clinical development, regulatory and statistical activities such as (co-)authoring and reviewing of documents.

Responsibilities

• Support creation of clinical documents such as study concepts, study protocols, amendments, study reports and investigator brochures.
• Assist in regulatory submissions/documents (e.g., NDA, MAA, IND, CTA, sNDA, DSUR, PIP) and health authority responses.
• Prepare presentations, abstracts, and manuscripts with the medical lead.
• Collaborate with data management on CRF design and completion guide.
• Develop data review plans and medical monitoring plans with the medical lead.
• Review protocol deviations and data eligibility; raise queries with the medical lead.
• Review safety data (SAEs, labs, efficacy, dosing) with the medical lead and pharmacovigilance.
• Ensure TMF compliance for clinical development documents.
• Provide site/protocol training for Site Initiation Visits and Investigator Meetings.

Skills

Oncology drug development

Clinical data interpretation

Regulatory familiarity

Education

PhD/PharmD or related Advanced Medical Degree

Job description

Taiho Oncology in Pleasanton, CA is seeking a Director, Clinical Research Scientist to lead design, execution and reporting of oncology trials (Phase 1–3) and support medical monitoring and CRS process improvements.

You will collaborate with medical leads, data management and statisticians to prepare regulatory submissions, study documents, and presentations while ensuring TMF compliance and high-quality scientific output.