Sr. Medical Director, Clinical Development

Looking for a chance to make a meaningful 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 highly value our employees, who work relentlessly to help 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 patients, the global healthcare community, collaborators and partners, and each other.

Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients.

Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients.

It’s our work, our passion, and our legacy.

We invite you to join us.

Hybrid

Employee Value Proposition:

At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most.

This is an exciting opportunity to lead global clinical trials and experience multiple facets of Clinical Development in a dynamic, supportive, collaborative, and global cross-functional environment.

Position Summary:

This position has direct responsibility for design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3.

Performance Objectives:


* Assume the medical leadership on global clinical trials for Taiho Oncology, Inc.

(TOI).


* Serve as a responsible clinical development lead and medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, as needed.


* Use medical/scientific expertise and strategic thinking to develop clinical development plans and study designs (incl.

use of companion diagnostics).


* Create or support the creation of relevant clinical documents of high quality, such as study protocol protocol(s), investigator brochure (IB), informed consent forms (ICF), case report forms (CRF), Clinical study report (CSR), NDA/MAA registration documents, and scientific publications.


* Answer medical questions raised by Competent Authorities (CA) and Institutional Review Boards/ Ethics Committees (IRBs/ECs) relevant to the studies.


* Review and sign off on clinical documents related to clinical studies as outlined by the manager.


* Attend study site initiation visits (SIV) and provides therapeutic area, compound, and protocol-specific trainings.


* Review, discuss, and answer any questions from the study sites regarding a patient’s eligibility, dose adjustments, and patient’s discontinuation.


* Perform data review supported by the CRS on an ongoing basis.

Review of the safety data will be done through data listings and t...