Director, Clinical Management- early phase, immunology/autoimmune

Job Summary

In collaboration with the Senior Director of Clinical Management, the Director is responsible for the operational strategy and management of Otsuka clinical programs, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution, and completion of clinical programs according to applicable regulations and guidance; ICH Guidelines, Good Clinical Practices (GCP), and Otsuka SOPs, within agreed upon timelines and budget.

Job Description

* Provides scientific clinical research and operational expertise in the development of overall strategy and objectives of the Global Clinical Development Plan (GCDP), including performing/overseeing and providing background research.

* May represent Clinical Management in the development of the Clinical Development Plan, timelines, and budget for Business Development opportunities.

* Ensures program specific standards (e.g., CRFs, outsourcing specifications, slides, training, templates) are developed and applied across all studies to ensure consistency of clinical dossier.

* Contributes to final analysis and interpretation including the development of clinical trial reports, publications, and internal/external presentations.

• Develops program level financial estimates and contributes to the MLTP. • Leads program level teams as Co-Chair and/or serves as lead clinical management representative for various meetings including, CRT/GBT/PDC/JDC/Alliance.

* Contributes to the preparation and defense of clinical program documents (investigator brochure (IB)/IMPD, IND/CTA annual reports, Health Authority briefing books and submissions (NDA, MA, NDS etc.), including ongoing maintenance of filings and support of labeling teams.

* Leads development of clinical sections of regulatory documents (i.e., Investigators’ Brochures, briefing books, submission dossier, and responses to Health Authorities que