Director – Clinical Management

🕒 July 6

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• In collaboration with the Senior Director of Clinical Management, the Director is responsible for the operational strategy and management of clinical development programs, with a strong preference for experience supporting Central Nervous System (CNS) therapeutic areas. • 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. • Represents 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.

🎯 Requirements

• Extensive experience in CNS drug development and clinical trial management, including oversight of global studies within psychiatric, neurologic, or other CNS-related therapeutic areas. • 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. • Significant pharmaceutical industry experience leading and managing clinical development programs in CNS therapeutic areas (e.g., psychiatry, neurology, neurodegenerative disorders, or related CNS indications). • Demonstrated experience supporting CNS clinical trials from early development through registration is strongly preferred. • Strong knowledge of global regulatory requirements and compliance, biostatistics, data management, and medical writing. • 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%. • Bachelor’s Degree with a minimum of 14 years of applicable pharmaceutical industry experience, including 10 years of clinical trial management experience. • Candidates should have substantial experience managing clinical programs within CNS therapeutic areas. • Previous supervisory experience required.

🏖️ Benefits

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • A generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs as well as other company provided benefits