Taiho Oncology
Sr. Director, Scientist Clinical Development (Biotech)
Looking for a chance to make a real difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also value our employees, who work relentlessly to help us execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of our patients, our partners, and each other. Together, we're working to discover and develop innovative cancer treatments that address unmet patient needs and apply the science behind them in novel ways. As the field of cancer treatment evolves, we evolve with it. Advanced technology, dedicated investigators, and incomparable facilities: these vast resources empower us to redefine the way the world treats cancer. It's our work, our passion, and our legacy. If the prospect of being part of this sounds exciting, we invite you to join us.
Hybrid Role: 2-3 days a week in office
Position Summary:
The Senior Director, Clinical Scientist, will lead and manage Taiho Oncology (TOI) Clinical Scientists. This role provides functional supervision to Clinical Scientists which includes skill development. This role identifies and implements best practices in trial management and execution. It is a key contact for Oncology trial management and execution. This role will be accountable for functional talent and career development of the other Clinical Scientists in collaboration with the medical. The role holder may also have their own projects.
Responsibilities and Duties:
Use medical/scientific expertise to create or support the creation of relevant clinical documents of high quality such as study concepts, study protocols, amendments, study reports, investigator brochures and scientific disclosures.
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)
Write sections of ICF/reviews ICF
Ensure appropriate CRF design, works with data management on CRF completion guide
Partners with data management to develop data review plan for review of data and with medical lead for the medical monitoring plan
Review patient eligibility, patient level and cumulative data per the data review plan across a study and coordinates with the medical lead for study level review
Review protocol deviations
Collaborates with the medical lead to provide medical/scientific guidance during the execution of the study
Develop specific medical/protocol training for Site Initiation Visits and Investigator Meetings, vendor / CRO staff, answers specific site protocol questions as needed in collaboration with the medical lead.
Educational Requirements:
Experience: