Senior Manager, Global Clinical Development; GCD - Metabolic Dietitian

Position: Senior Manager, Global Clinical Development (GCD) - Metabolic Dietitian
## Senior Manager, Global Clinical Development (GCD) - Metabolic Dietitian Apply locations:
Remote time type:
Full time posted on:
Posted Yesterday job requisition :
R12432

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. The specific duties assigned to the Senior Manager, Metabolic Dietitian include the following:
* 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.

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