Director, Clinical Research Scientist

About the role

The Director, Clinical Research Scientist at Taiho Oncology plays a pivotal role in driving innovative clinical research and contributing to groundbreaking therapies. This role involves assisting in the design, execution, and reporting of clinical oncology trials ranging from phase 1 to 3. Additionally, this role supports the medical monitor or a Lead medical monitor for various clinical phase 1 to 3 trials.

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 for 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 preparation of Informed Consent Forms (ICFs) and reviews ICFs.
• Collaborates with data management on CRF design and completion guides. Assists in developing data review plans and medical monitoring plans.
• Reviews protocol deviations, patient eligibility, and patient-level and cumulative data per the data review plan across a study, raising queries and coordinating 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 Trial Master File (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 Statistical Analysis Plan (SAP) and statistical outputs, in collaboration with the statistician, medical writer, and medical lead.
• Reviews the Case Report Form (CRF) and Case Report File (CRF), in collaboration with the medical writer and medical lead, and/or any related publications (abstracts; presentations at meetings or publications in scientific journals).

Requirements

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

• Experience in oncology is a must.
• Ability to follow independently delegated activity linked to clinical research scientist function, communicate progress and understand timelines.

Skills

• Medical/scientific expertise.
• Collaboration and communication skills.
• Attention to detail.
• Problem-solving skills.
• Ability to work independently and as part of a team.

Benefits

Taiho Oncology offers a competitive compensation package, including a base salary range of $238,000 - $280,000 annually, along with other benefits such as a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave).

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.