Director, Clinical Research Scientist

Taiho Oncology, Inc.•Pleasanton, CA

147d•$238,000 - $280,000•Hybrid

About The Position

The Director, Clinical Research Scientist assists in 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 various trials, and works with the Clinical Research Scientist Manager on process improvement as needed. This position applies medical and scientific expertise to clinical study documents, regulatory submissions, study data review, medical monitoring, training, and study reporting. The Director collaborates with medical leads and cross-functional partners to support clinical development 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 previous 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 clinical research scientist activities, communicate progress, and understand timelines.

Responsibilities

Support the creation of 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.
Provide input into or 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 in collaboration 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-related issues requiring complex medical expertise to the medical lead and operational issues to the appropriate study operations team member.
Review statistical analysis plans (SAPs) and statistical outputs with the statistician, medical writer, and medical lead.
Review interim, final, and addendum clinical study reports (CSRs), and related publications, abstracts, and meeting presentations with the medical writer and medical lead.
Assist with other asset activities requiring clinical or scientific expertise.
Assist with clinical research scientist process improvement as needed.