Senior Manager, Global Clinical Development (GCD) - Metabolic Dietitian

Senior Manager, Global Clinical Development (GCD) - Metabolic Dietitian 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 provide dietary and metabolic expertise to support the design, execution, and oversight of clinical research programs under Good Clinical Practice (GCP). Responsibilities 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 Required: 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. Preferred: Experience in pharmaceutical or biotech clinical development. Familiarity with GCP and regulatory requirements. Experience with protocol development, site training, and/or real‑world evidence generation. Established network within the metabolic dietitian community. Experience engaging with professional organizations (e.g., GMDI). Competencies Accountability for Results – Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving – Make decisions considering the long‑term impact to customers, patients, employees, and the business. Patient & Customer Centricity – Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication – Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration – Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development – Play an active role in professional development as a business imperative. Compensation Minimum $150,034.00 – Maximum $224,250.00, plus incentive opportunity. The range shown represents a typical pay range or starting pay for individuals hired in the United States. Actual pay may be positioned within the range based on experience, skills, and internal comparison. 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; generous 401(k) match; flexible time off, paid holidays, paid leave programs; and other company‑provided benefits. Equal Opportunity Employer Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to apply to this job opening as a result of your disability. Contact Accommodation Request (View email address on click.appcast.io) for assistance. #J-18808-Ljbffr Otsuka America Pharmaceutical Inc.