Director of Quantitative Pharmacology and Pharmacometrics

7 days ago

Rockville, Maryland, United States Otsuka Pharmaceutical Co., Ltd. Full time
Job Description

Otsuka Pharmaceutical Company is a global healthcare company with a strong commitment to innovation and improving patient outcomes. As a Director of Quantitative Pharmacology and Pharmacometrics, you will play a critical role in advancing drug development by serving as the key expert on all pharmacometrics matters relating to assigned clinical projects.

Key Responsibilities:

  • Oversee all pharmacometrics activities related to pre-IND, IND, phase 1-3, PK, PK/PD, and regulatory submissions.
  • Lead analysis, execution, and reporting of pharmacometrics studies.
  • Provide input into all phases of drug development, including dose finding, dose optimization, exposure-response, and pediatric development.
  • Collaborate with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance, and drug interaction studies.

Requirements:

  • PhD in pharmacometrics or a related area with a minimum of 8-10 years of industry experience.
  • Strong technical and hands-on experience in population PK and PK/PD modeling.
  • In-depth knowledge of pharmacometrics, population PK, and PK/PD modeling, clinical pharmacology, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
  • Excellent working knowledge of phase 1 clinical operations, drug development, multi-region regulatory requirements, and formulation development.

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.

Benefits:

  • Comprehensive medical, dental, vision, and prescription drug coverage.
  • Company-provided Basic Life, AD&D, Short-term, and Long-term Disability insurance.
  • Tuition reimbursement.
  • 401(k) match.
  • PTO allotment each calendar year.
  • Paid holidays.
  • Paid leave programs.

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 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.

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