Director, Clinical Management Early Phase, CNS

Director, Clinical Management

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.

• 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 questions) and inspection readiness programs, where appropriate.

• Develops strong scientific partnership with key advisors in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Leads program-related advisory boards/committees and meetings.

• Supports the design & implementation of a program level HEOR strategy, including endpoint development where necessary.

• Serves as contact for Medical Affairs/PBS related to medical information requests, public disclosure of information (e.g., clinicaltrials.gov) and publications strategies.

• Represents assigned programs to senior management and OPCJ and disseminates information and tasks to team members.

• Participates in External Service Provider (ESP) partnership governance and alliance management activities as assigned.

• Assists Senior Director with portfolio level resource planning.

• Gives direction, training, and support to Clinical Management personnel within program/compound team.

• Participates in ongoing review of clinical trial data focusing on data integrity, trending, and consistency.

• Ensures inspection readiness activities are planned and conducted appropriately across program.

• Participate in program-level risk mitigation activities.

• Represent Clinical Management in departmental and cross-functional initiatives, as assigned.

• Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts.

• May have supervisory responsibilities including:

• Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes.
• Assuring compliance with departmental, SOP, compliance, and corporate training.
• Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.
• Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.

• Performs other duties, as assigned.

Qualifications/ Required Knowledge/ Experience and Skills:

• Comprehensive knowledge of clinical operations, drug development process, standard operating procedures (SOPs) and GCP/ICH regulations.

• Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW).

• Advanced understanding of drug development principles and clinical trial implementation and management.

• Strong knowledge of global regulatory requirements and compliance, biostatistics, data management, and medical writing.

• Strong communication, organization, planning, analytical, problem solving, and people management skills.

• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.).

• Ability to travel up to 25%.

Educational Qualification Required:

• Bachelor's Degree with a minimum of 14 years of applicable pharmaceutical industry experience including 10 years clinical trial management experience. Previous supervisory experience.

Preferred:

• Advanced Degree