Sr. Medical Director, Clinical Development

We are looking for a Sr. Medical Director, Clinical Development to lead global clinical trials and experience multiple facets of Clinical Development in a dynamic, supportive, collaborative, and global cross-functional environment.

Requirements

• 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.
• 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.
• Build and maintain effective relationships with clinical key opinion leaders in various different areas of disease in which Taiho is developing drugs.
• Collaborate with all department heads within TOI (Head of Clinical Research and Head of Clinical Operations) to establish operational plans and timelines for respective studies within each of the development programs

Benefits

• 401(k) eligibility
• Vacation
• Sick time
• Parental leave