Director, Clinical Management – Early Phase, Rare/Specialty Disease

🕒 June 29

🇺🇸 United States – Remote

💵 $186.5k - $278.9k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 21%

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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

• Develop and oversee the operational strategy and objectives of Global Clinical Development Plans • Plan, execute, and complete clinical programs according to regulations, ICH Guidelines, GCP, and Otsuka SOPs within timelines and budget • Represent Clinical Management in Clinical Development Plan, timeline, and budget development for Business Development opportunities • Develop and apply program-specific standards across studies • Contribute to final analysis, interpretation, clinical trial reports, publications, and presentations • Develop program-level financial estimates and contribute to the MLTP • Lead program-level teams and represent Clinical Management in cross-functional meetings • Prepare and defend clinical program documents, regulatory submissions, and Health Authority briefing materials • Lead clinical sections of regulatory documents and inspection-readiness programs • Build scientific partnerships with key advisors and lead advisory boards, committees, and meetings • Support program-level HEOR strategy and endpoint development • Coordinate with Medical Affairs/PBS on medical information requests, public disclosure, and publication strategies • Represent assigned programs to senior management and disseminate information and tasks to team members • Participate in ESP partnership governance and alliance management • Assist with portfolio-level resource planning • Provide direction, training, and support to Clinical Management personnel • Review clinical trial data for integrity, trends, and consistency • Plan and conduct inspection-readiness activities • Participate in program-level risk mitigation and departmental, cross-functional, ESP, and corporate initiatives • Lead or contribute to standardization and continuous-improvement efforts • Coordinate onboarding and training, ensure compliance and access to required resources, set performance expectations, and provide feedback when supervising staff • Perform other assigned duties

🎯 Requirements

• Comprehensive knowledge of clinical operations, drug development processes, SOPs, and GCP/ICH regulations • Thorough knowledge of CROs, outsourcing, and evaluating vendor work against Statements of Work (SOW) • Advanced understanding of drug development principles and clinical trial implementation and management • Strong knowledge of global regulatory requirements, compliance, biostatistics, data management, and medical writing • Strong communication, organization, planning, analytical, problem-solving, and people-management skills • Strong computer skills and demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook • Good understanding of clinical trial software such as eCRFs, IRT, and CTMS • Ability to travel up to 25% • Bachelor’s Degree • Minimum 14 years of applicable pharmaceutical industry experience, including 10 years of clinical trial management experience • Previous supervisory experience

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity