Associate Director Clinical Pharmacology

Job Locations US-MD-Rockville
Requisition ID
2018-10109

Responsibilities

Can work out of Princeton, NJ or Rockville, MD office.

 

Actively participates and contributes to the study design and reporting of Clinical Pharmacology studies. Provides input into all phases of drug development including, but not limited to, dose finding, dose optimization, exposure-response and pediatric development. Closely interacts with nonclinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. Author of Clinical Pharmacology submission documents and representative of the department at different product development team meetings. Works closely with Pharmacometrics and Simulation and Modeling team members to provide input on modeling and simulation activities. 

  • Development and review of protocol outlines, protocols, pre-study, during study and post-study clinical activities
  • PK and PK/PD study design, analysis and reporting, of PK and PK/PD studies.
  • Work with pharmacometricians on Population PK/PD design, analysis and reporting
  • Conduct PK/PD modeling and simulation 
  • Update PK/PD development plans and the Clinical Pharmacology sections of Global Development & Commercialization Plans
  • Development of relevant sections for regulatory filings including Annual updates, IB updates, Investigational New Drugs and New Drug Applications
  • Works with Bioanalytical team members on:
    • Assay development, sample management and bioanalytical activities
    • Pharmacogenomics and pharmacogenetics activities
    • Selection and analysis of biomarkers
  • Works with formulation development groups with regard to:
    • Formulation development, dissolution testing, in vivo-in vitro correlations for pre- and post-approval formulations.
  • Manage outsourcing of PK and PK/PD analyses and reports, including contract requisition, SOW and approval of invoices
  • Training and mentoring of junior staff.
  • Compliant with SOPs, policies, and procedures
  • Reviewing processes and procedures and recommending changes, where necessary
  • Liaises with external functions and affiliates.
  • Supports corporate and departmental goals.
  • Serves as Clinical Pharmacology team member on multiple project teams and as a team member on other key projects as needed.

Travel 20%

 

Qualifications

Knowledge

  • Requires working knowledge of clinical pharmacology including pharmacokinetics, pharmacodynamics, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
  • Knowledge of Phase I clinical operations, pharmacometrics, general pharmacology, pharmacogenetics, and regulatory requirements related to clinical pharmacology.
  • Working knowledge of formulation development, drug development, PK/PD modeling and simulation.
  • Knowledge of nonclinical requirements and bioanalytical assays for clinical trials
  • Understanding of the company’s products and the pharmaceutical industry in general.
  • Familiarity with pharmacogenomics in drug development.
  • Current awareness of the latest developments in clinical pharmacology.

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 organization skills.
  • Strong communication skills.
  • Experience with regulatory submission process (IND, NDA, MAA) desirable
  • Hands-on experience with modeling and simulation software (R, NONMEM, Phoenix NLME, Monolix) desirable. 
  • Flexibility to react rapidly to changing situations/environment

Required education and experience

  • PhD in Pharmacokinetics, Clinical Pharmacology, Pharmacology, or a related area.
  • Minimum of 5 years of experience in these areas 

Overview

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.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 


All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

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