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

Otsuka America Pharmaceutical Inc.

St Thomas, VI

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JOB DETAILS

SKILLS

Analysis Skills, Biostatistics, Biotech and Pharmaceutical, Clinical Data, Clinical Outcomes, Clinical Research, Clinical Support, Clinical Trial, Communication Skills, Consulting, Contract Research Organization (CRO), Data Collection, Dietary Management, Dietetics, Drug Development, GCP (Good Clinical Practices), Internet Application, Medical Affairs, Medical Office, Medical Office Administration, Metabolic Disorders, Nutrition, People Management, Problem Solving Skills, Protocol Design, Regulations, Regulatory Requirements, Resume Search, Yahoo!

LOCATION

St Thomas, VI

POSTED

2 days ago

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; https://www.otsuka-us.com/careers-join-otsuka . **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 (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

About the Company

Otsuka America Pharmaceutical Inc.

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