Associate Director, Quantitative Pharmacology, Clinical Pharmacology
Company: Otsuka Pharmaceutical
Location: Rockville
Posted on: January 20, 2023
Job Description:
Job SummarySupport all clinical pharmacology activities related
to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions.
Support study design, execution and reporting of clinical
pharmacology and studies. Provide input into all phases of drug
development including dose finding, dose optimization,
exposure-response and pediatric development. interact with
non-clinical 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. Participate in pharmacometrics and simulation and
modeling plans and contribute to modeling and simulation
activities. Interact with early development and business
development team members and external collaborators to assess/lead
development and selection of pre-IND and early phase assets.Job
Description
- Support clinical pharmacology activities related to study
design, protocol development, study execution, reporting and
interpretation of data.
- Conduct PK and PK/PD analysis.
- Work with pharmacometrics team members and provide input
related to analysis of PK and PK/PD.
- Author development of clinical pharmacology sections for
regulatory filings including annual reports, investigator's
brochure, IND/NDA applications and pediatrics development
plans.
- Work with bioanalytical team members on activities related to
assay development, sample management, pharmacogenomics and
biomarker development.
- Work with formulation development groups and provide support
for activities related to formulation development, dissolution
testing, in vivo-in vitro correlations and biowaivers for pre- and
post-approval formulations.
- Manage clinical pharmacology activities related to project
budgets, outsourcing of PK and PK/PD analyses, contract
requisition, SOW and approval of invoices.
- Mentor staff related to clinical pharmacology
- Serve as clinical pharmacology lead and pharmacometrics
representative on multiple project teams and support model-based
drug development strategies for ongoing projects.Qualifications/
RequiredKnowledge/ Experience:
- In-depth knowledge of clinical pharmacology, PK, PD, drug
metabolism, biopharmaceutics, and bioanalytical chemistry, Hands PK
and PK/PD analysis and, Phoenix NLME.
- Excellent working knowledge of phase I clinical operations,
drug development, multi-region regulatory requirements and PK/PD
analysis.
- Great working knowledge of formulation development, drug
development and clinical development.
- Current awareness of the latest developments in clinical
pharmacology, pharmacometrics and guidance documents.Skills
- Will apply scientific knowledge (in the areas specified above)
to further our products, identify core problems, and apply
analysis.
- Experience related to clinical pharmacology.Educational
Qualifications
- PhD, PharmD, MS in Clinical Pharmacology (or a related area
such as pharmacokinetics, pharmacology, pharmaceutics) with a
minimum of 5 years of experience in these areas.
- Experience in population PK and PK/PD modeling and statistical
models a plus.#MS1
Keywords: Otsuka Pharmaceutical, Rockville , Associate Director, Quantitative Pharmacology, Clinical Pharmacology, Executive , Rockville, Maryland
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