Director, Clinical Research Scientist

Taiho Oncology, Inc. • Pleasanton, CA

46d • $238,000 - $280,000 • Hybrid

About The Position

The Director, Clinical Research Scientist assists with the design, execution, and reporting of current and future Phase 1–3 clinical oncology trials. The role supports a responsible medical monitor or serves as a lead medical monitor for assigned trials, and assists the Clinical Research Scientist Manager with process improvement as needed. The position works closely with medical leads and cross-functional partners to support clinical research activities and contribute to the development of cancer therapies.

Requirements

• PhD, PharmD, or another related advanced medical scientific degree.
• Oncology experience is required.
• At least 3 years of experience in the oncology drug development industry, with prior exposure to clinical development, regulatory, and statistical activities, such as co-authoring and reviewing documents.
• Ability to critically review and interpret clinical data.
• Working knowledge of the drug development process in the United States and European Union.
• Ability to learn and integrate complex information and communicate clinical information clearly to non-clinical team members.
• Ability to independently follow delegated activities related to the clinical research scientist function, communicate progress, and understand timelines.

Responsibilities

• Support development of high-quality clinical documents, including study concepts, protocols, amendments, study reports, and investigator brochures.
• Assist the medical lead in preparing clinical content for regulatory submissions and documents, including NDA, MAA, IND, CTA, sNDA, DSUR, PIP, health authority and ethics committee responses, and briefing packages.
• Work with the medical lead to prepare internal and external presentations, abstracts, and manuscripts.
• Contribute to and review informed consent forms (ICFs).
• Work with data management on case report form (CRF) design and completion guides.
• Partner with data management to develop data review plans and with the medical lead to develop medical monitoring plans.
• Review protocol deviations, patient eligibility, and patient-level and cumulative study data; raise queries and coordinate with the medical lead.
• Review safety data with the medical lead, including SAE reports with pharmacovigilance, laboratory results, efficacy data, dosing data, and withdrawals or discontinuations.
• Collaborate with the medical lead to provide medical and scientific guidance during study execution.
• Ensure compliance of clinical development and medical study-level documents with the trial master file (TMF).
• Answer site protocol questions as needed after consulting with the medical lead.
• Develop medical and protocol training for Site Initiation Visits, Investigator Meetings, and vendor or CRO staff in collaboration with the medical lead.
• Escalate protocol issues requiring complex medical expertise to the medical lead and operational issues to the appropriate study operations team member.
• Review the statistical analysis plan (SAP) and statistical outputs in collaboration with the statistician, medical writer, and medical lead.
• Review interim, final, and addendum clinical study reports (CSRs), and related publications, in collaboration with the medical writer and medical lead.
• Assist with other asset activities requiring clinical or scientific expertise.

Benefits

• Annual bonus or incentive compensation plans may be included in the total compensation package.
• Potential long-term incentive plan and discretionary awards may be included.
• Medical, financial, and other benefits.
• 401(k) eligibility.
• Paid time off benefits, including vacation and sick time.
• Parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree