[Hiring] Senior Manager, Global Clinical Development (GCD) - Metabolic Dietitian @Otsuka Pharmaceutical Co., Ltd.

Role Description

Otsuka is seeking a Senior Manager, Global Clinical Development (GCD) - Metabolic Dietitian based remotely or in our Princeton, NJ or Rockville, MD offices, who will be responsible for providing dietary and metabolic expertise to support the design, execution, and oversight of clinical research programs under Good Clinical Practice (GCP). The incumbent will support the clinical development of therapies for Rare Diseases and Inherited Metabolic Disorders (e.g., PKU, UCD, MSUD) across multiple stages of development.

• Consults with investigators, site dietitians, patients, and cross‑functional partners and applies insights to optimize study design, dietary endpoints, and protocol implementation.
• Serves as a metabolic nutrition subject‑matter expert, supporting clinical development, medical affairs, regulatory, and other project team members.
• Provides input into protocol design and study strategy, particularly for trials involving dietary interventions, normalization, and metabolic endpoints.
• Oversees dietary data collection and quality, ensuring consistency, accuracy, and adherence to protocol‑specified dietary guidelines.
• Supports site selection, training, and ongoing engagement of site dietitians and investigators.
• Provides guidance on dietary variability and its impact on clinical endpoints, ensuring appropriate interpretation of study results.
• Collaborates cross‑functionally with Clinical Operations, Biostatistics, Regulatory, and Medical Affairs to support study execution and data interpretation.
• Contributes to analysis and communication of clinical trial results, integrating dietary context into scientific outputs.
• Supports post‑approval readiness and real‑world implementation, ensuring alignment between clinical data and dietary practice.
• Engages with external stakeholders, including metabolic dietitian networks, professional societies (e.g., GMDI), and key opinion leaders.
• Supports vendor and CRO interactions related to dietary components of clinical trials.

Qualifications

• Registered Dietitian (RD/RDN) with expertise in metabolic or inherited metabolic disorders.
• ≥ 5 years of experience in clinical practice, clinical research, or pharmaceutical/biotech industry.
• Demonstrated experience in dietary management of PKU and/or other IEMs.
• Experience supporting or participating in clinical research or clinical trials.
• Strong understanding of dietary assessment methods and metabolic clinical endpoints.
• Ability to communicate effectively in meetings and via written and oral presentations.
• Experience working in cross‑functional, matrixed environments.

Requirements

• Experience in pharmaceutical or biotech clinical development (preferred).
• Familiarity with GCP and regulatory requirements (preferred).
• Experience with protocol development, site training, and/or real‑world evidence generation (preferred).
• Established network within the metabolic dietitian community (preferred).
• Experience engaging with professional organizations (e.g., GMDI) (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 and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.