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 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. Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States.

Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum.

This information is provided to applicants in accordance with states and local laws. Application Deadline: This will be posted for a minimum of 5 business days.

Company 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, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; otsuka-us.com. Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position.

Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 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. You can request reasonable accommodations by contacting Accommodation Request.

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Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.”

In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other.

It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The