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Open Position at Otsuka: Associate Director Clinical Pharmacology

From: Shankar Lanke <shankarlanke>
Date: Tue, 23 Jan 2018 11:48:08 -0500

Dear All,

We have an opening in our department Associate Director Clinical
Pharmacology at Otsuka Pharmaceuticals

Associate Director Clinical Pharmacology
Job Locations US-MD-Rockville
Requisition ID2018-10109

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
   - Work with pharmacometricians on Population PK/PD design, analysis and
   - 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
   - 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
   - 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%


   - Requires working knowledge of clinical pharmacology including
   pharmacokinetics, pharmacodynamics, drug metabolism, biopharmaceutics, a=
   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.


   - Must be able to apply scientific knowledge (in the areas specified
   above) to further the company’s products, anticipate and identif=
y core
   problems, apply insightful analysis, and solve problems effectively.
   - Strong organization skills.
   - Strong communication skills.
   - Experience with regulatory submission process (IND, NDA, MAA) desirabl=
   - 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


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

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” compan=
y 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 Learn more about Otsuka in the U.S. at

Shankar Lanke Ph.D.

Received on Tue Jan 23 2018 - 11:48:08 EST

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