Taiho is looking for a Director, Clinical Research Scientist to join our oncology development team. This role is responsible for assisting in the design, execution, and reporting of clinical oncology trials from phase 1 through 3. At Taiho, we are dedicated to transforming the landscape of cancer treatment and improving patients' lives, guided by a "people first" approach that values accountability, collaboration, and trust.
What You'll Do
- Use medical and scientific expertise to support the creation of high-quality clinical documents like study concepts, protocols, amendments, reports, and investigator brochures.
- Assist the medical lead in preparing clinical content for regulatory submissions including NDA, MAA, IND, CTA, sNDA, DSUR, and PIP.
- Partner with the medical lead to develop presentations, abstracts, and manuscripts.
- Provide input into the review of Informed Consent Forms (ICF).
- Collaborate with data management on Case Report Form (CRF) design and completion guides.
- Develop data review and medical monitoring plans with data management and the medical lead.
- Review protocol deviations, patient eligibility, and cumulative data per the data review plan, raising queries as needed.
- Review safety data, SAE reports, labs, efficacy data, dosing data, and patient withdrawals in collaboration with pharmacovigilance and the medical lead.
- Provide medical and scientific guidance during study execution.
- Ensure Trial Master File (TMF) compliance for clinical development documents.
- Answer specific site protocol questions after consulting with the medical lead.
- Develop medical and protocol training for Site Initiation Visits, Investigator Meetings, and vendor/CRO staff.
- Escalate complex medical issues to the medical lead and operational issues to the study team.
- Review the Statistical Analysis Plan (SAP) and statistical outputs with the statistician, medical writer, and medical lead.
- Review Clinical Study Reports (CSR) and related publications in collaboration with the medical writer and lead.
- Assist in other asset activities requiring clinical and scientific expertise.
What We're Looking For
- A PhD, PharmD, or other related Advanced Medical Scientific Degree.
- Experience in oncology is required.
- At least 5 years in the drug development industry within oncology, with previous exposure to clinical development, regulatory, and statistical activities.
- Ability 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 clearly to non-clinical team members.
- Ability to independently follow delegated activities linked to the clinical research scientist function, communicate progress, and understand timelines.
Benefits & Compensation
- Compensation range: $238k - $280k annually.
- 401(k) eligibility.
- Paid time off benefits including vacation, sick time, and parental leave.
- Medical, financial, and/or other benefits.
Work Mode
This position operates on a hybrid work model.
Taiho is an equal opportunity employer.
