Taiho Oncology, Inc. · 1 day ago
Associate Director, Clinical Research Scientist
Pleasanton, CA
Full-time
Hybrid
Lead/Staff, Director/Executive
$213K/yr - $251K/yr
3+ years expTaiho Oncology is dedicated to improving the lives of patients with cancer through innovative research and therapies. As an Associate Director, Clinical Research Scientist, you will be responsible for designing, executing, and reporting on clinical oncology trials, while collaborating with various teams to ensure the success of these trials.
BiotechnologyHealth CareMedicalOncologyPharmaceutical
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
Qualification
Required
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
Benefits
Annual bonus/incentive comp plans
Potential long term incentive plan
Discretionary awards
Full range of medical, financial, and/or other benefits
401(k) eligibility
Various paid time off benefits, such as vacation, sick time, and parental leave
Company
Taiho Oncology, Inc.
The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers.
201-500 employees
H1B Sponsorship
Taiho Oncology, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (5)
2023 (1)
2021 (3)
Funding
Current Stage
Growth StageLeadership Team
Tim Whitten
CEO & President
Michael Schick
Senior Vice President, Chief Commercial Officer
Recent News
2025-12-03
Pharma Letter
2025-11-22
Company data provided by crunchbase