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Associate Director, Quantitative Pharmacology, Pharmacometrics
Otsuka Pharmaceutical Co., Ltd. Rockville, MD
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Associate Director, Quantitative Pharmacology, Pharmacometrics

Otsuka Pharmaceutical Co., Ltd.
Rockville, MD
  • Full-Time

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

As an Associate Director, Quantitative Pharmacology, Pharmacometrics, you will play a pivotal role in informing drug development strategies and decision making, optimizing study designs, and supporting regulatory submissions and interactions by applying pharmacometric principles and methodologies. The successful candidate will develop and implement model-informed drug development (MIDD) across the development portfolio and collaborate with cross-functional teams to optimize drug development strategies.

You will report to the Director, Quantitative Pharmacology, Pharmacometrics. This position's location is flexible, with our Princeton, NJ or Rockville, MD offices included in consideration. Otsuka maintains a hybrid work policy and travel is expected based on business needs. This position is open to being remote.

Job Description

  • Conduct pharmacometrics activities related to pre-IND, IND, phase1-3, regulatory meetings and regulatory submissions.
  • Provide pharmacometrics analysis and participates in activities related to analysis and reporting of pharmacometrics analyses.
  • Author pharmacometrics sections of clinical pharmacology documents for regulatory filings including investigator's brochure, IND/NDA/BLA applications, pediatrics development plans, and etc.
  • Manage pharmacometrics activities related to project budgets, outsourcing of pharmacometrics analyses, contract requisition, and SOW.
  • Serve as pharmacometrics lead on project teams and interact with cross-functional teams including clinical pharmacology, clinical development, safety, biostatistics, regulatory and etc. to support model-based drug development strategies for all phases of drug development programs.


Qualifications/ Required

Knowledge/ Experience and Skills:
  • Strong technical and hands on experience in pharmacometrics modeling.
  • In-depth knowledge of pharmacometrics, population PK and PK/PD modeling, clinical pharmacology, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
  • Hands PK and PK/PD analysis and statistical analysis using NonMEM, Phoenix NLME, R etc,
  • Excellent working knowledge of phase I-III clinical trials, drug development, multi-region regulatory requirements.
  • Good working knowledge of formulation development, drug development and clinical development.
  • Current awareness of the latest developments in clinical pharmacology and guidance documents.


Skills:
  • Must be able to apply scientific knowledge (in the areas specified above) to further the company's products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.
  • Strong technical and hands on experience related to pharmacometrics, population PK and PK/PD modeling
  • Strong organization skills.
  • Strong communication skills.
  • Flexibility to react rapidly to changing situations/environment

Educational Qualifications
  • PhD in pharmacometrics (or a related area such as pharmacokinetics, clinical pharmacology, pharmacology, or a related area) with 4+ years of experience in these areas.

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.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

#LI Hybrid

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.

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.

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 ODH, 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.

Address

Otsuka Pharmaceutical Co., Ltd.

2440 Research Blvd

Rockville, MD
20850 USA

Industry

Technology

Posted date

February 14, 2024

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Otsuka Pharmaceutical Co., Ltd. job posting for a Associate Director, Quantitative Pharmacology, Pharmacometrics in Rockville, MD with a salary of $73,900 to $105,000 Yearly with a map of Rockville location.