Director, Clinical Management, Early Phase, CNS

🕒 June 29

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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

• Provides scientific clinical research and operational expertise in the development of overall strategy and objectives of the Global Clinical Development Plan (GCDP) • May represent Clinical Management in the development of the Clinical Development Plan, timelines, and budget for Business Development opportunities • Ensures program specific standards are developed and applied across all studies • Contributes to final analysis and interpretation including the development of clinical trial reports, publications, and internal/external presentations • Develops program level financial estimates • Leads program level teams as Co-Chair and/or serves as lead clinical management representative for various meetings • Contributes to the preparation and defense of clinical program documents • Leads development of clinical sections of regulatory documents and inspection readiness programs • Develops strong scientific partnership with key advisors in assigned therapy area • Supports the design & implementation of a program level HEOR strategy • Serves as contact for Medical Affairs/PBS related to medical information requests • Represents assigned programs to senior management and OPCJ • Participates in External Service Provider (ESP) partnership governance and alliance management activities as assigned • Assists Senior Director with portfolio level resource planning

🎯 Requirements

• 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 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 clinical trial management experience • Previous supervisory experience • Advanced Degree preferred

🏖️ 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 • Other company provided benefits