Director, Clinical Research Scientist

About the role

Taiho Oncology is 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.

Responsibilities

• Supports the creation of relevant clinical documents of high quality such as study concepts, study protocols, amendments, study reports, and investigator brochures.
• Prepares clinical content of regulatory submissions/documents (e.g., NDA, MAA, IND, CTA, SNDA, DSUR, PIP, health authority/ethics committee responses, briefing packages).
• Prepares presentations (internal and external), abstracts, manuscripts, and inputs into the ICF/reviews ICF.
• Works with data management on CRF design and completion guides, develops data review plans, and assists in 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.
• Affords assistance in any other asset activities requiring clinical/scientific expertise.

Requirements

• PhD, PharmD, or other related Advanced Medical Scientific Degree.
• At least 3 years in drug development industry in oncology and with previous exposure to clinical development, regulatory, and statistical activities.
• Working knowledge of the drug development process in the USA and EU.
• Ability to critically review and interpret clinical data.
• 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.

Qualifications

• Knowledge of oncology.
• Experience in clinical development, regulatory, and statistical activities.
• Ability to communicate clinical information effectively.
• Ability to learn and integrate complex information.

Skills

• Medical/scientific expertise.
• Collaborative and inclusive work environment.
• Ability to escalate issues requiring complex medical expertise.
• Ability to follow delegated activity and communicate progress.

Benefits

Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Pay

The pay range for this position at commencement of employment is expected to be between $238,000- $280,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.