Director, Clinical Research Scientist

Taiho Oncology, Inc.•Pleasanton, CA

1d•$238,000 - $280,000•Hybrid

About The Position

At Taiho Oncology, we are dedicated to transforming the landscape of cancer treatment and improving patients' lives. As a Director, Clinical Research Scientist, you will play a pivotal role in our mission, leveraging your expertise to drive innovative clinical research and contribute to groundbreaking therapies. We offer a collaborative and inclusive work environment where your ideas and contributions are valued. Join us to advance your career, work with passionate and skilled professionals, and make a meaningful impact on the fight against cancer. At Taiho Oncology, you will find purpose, growth, and the opportunity to be at the forefront of cancer research. The Director, Clinical Research Scientist has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3. Additionally, this role serves in assisting the responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, and assisting the Clinical Research Scientist Manager to contribute to CRS process improvement, as needed.

Requirements

PhD, PharmD or other related Advanced Medical Scientific Degree.
Experience in oncology is a must.
At least 3 years in drug development industry in oncology and with previous exposure to clinical development, regulatory and statistical activities such as, e.g., (co-)authoring and reviewing of documents.
Ability to critically review and interpret Clinical data.
Working knowledge of the drug development process in the USA and EU is required.
Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members.
Ability to follow independently delegated activity linked to clinical research scientist function, communicate progress and understand timelines.

Responsibilities

Uses medical/scientific expertise to support the creation of relevant clinical documents of high quality such as study concepts, study protocols, amendments, study reports and investigator brochures.
At the asset level, assists the medical lead in the preparations of the clinical content of regulatory submissions/documents (e. g. NDA, MAA, IND, CTA. sNDA, DSUR, PIP, health authority/ethics committee responses, briefing packages).
Works with the medical lead to prepare presentations (internal and external), abstracts, manuscripts.
Inputs into the of ICF/reviews ICF.
Works with data management on CRF design and completion guide.
Partners with data management to develop data review plan for review of data and with medical lead for the medical monitoring plan.
Reviews protocol deviations, patient eligibility, and patient level and cumulative data per the data review plan across a study, raises queries and coordinates with the medical lead.
Reviews safety data with the medical lead, SAE reports (in collaboration with pharmacovigilance), labs, efficacy data, dosing data, withdrawals/discontinuations.
Collaborates with the medical lead to provide medical/scientific guidance during the execution of the study.
Ensures TMF compliance for clinical development/medical study level TMF documents.
Answers specific site protocol questions as needed, after consultation with the medical lead.
Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, vendor / CRO staff, in collaboration with the medical lead.
Escalates protocol-related issues requiring complex medical expertise to the medical lead, and operational issues to the appropriate operations study team member.
Reviews the SAP and statistical outputs, in collaboration with the statistician, medical writer, and medical lead.
Reviews the CSR (interim; final; addendum), in collaboration with the medical writer and medical lead and/or any related publications (abstracts; presentations at meetings or publications in scientific journals) in relation with medical writer and medical lead.
Assist in any other asset activities requiring clinical/ scientific expertise.