Position

Head of Management/CFO Candidate

Reporting to

Clinical Development Head

Description

Formulate and manage individual development plans for our own pipeline from both a managerial and scientific perspective (TPP, CDP, schedule), including:

a. Formulation and implementation of clinical trial protocols.

b. Conducting clinical trials within agreed timelines, budget, and quality based on the clinical trial plan.

c. Preparation for and conducting consultations with PMDA.

d. Close coordination with each stakeholder including Principal Investigators (PI), CROs, and hospitals (including AROs and SMOs).

e. Preparation of IND and NDA documents.

f. Preparation of clinical trial reports.

g. CRO management.

h. Utilization of the Scientific Advisory Board and various advisors and consultants.

i. Creation and management of SOPs (QC/QA).

Requirements/Skills

Must

• Experience as a project leader in successfully designing development strategies that not only confirm safety and dosing in Phase 1 but also indicate efficacy in subsequent development stages.
• Experience in clinical development operations in other therapeutic areas.
• Experience in preparing submissions for regulatory authorities.
• Experience in setting expectations with PIs, hospitals, and CROs, identifying mutual benefits, and completing the designated development program.

Nice to Have

• Development experience in the oncology treatment area.
• Experience in successfully designing development strategies that not only confirm safety and dosing in Phase 1 but also indicate efficacy in subsequent development stages.
• Experience in strategic planning and execution for obtaining accelerated approval from regulatory authorities.
• Experience in planning and executing clinical development programs in Europe and the USA.
• Experience in clinical development operations within a biotech company.