Dear all,
Come work with me (and the incomparable Pete Bonate!) by joining an amazing
group of scientists working on exciting drug development projects! We are
looking for a Pharmacometrician for our team at Astellas.
Click the link and/or reach out directly:
https://astellascareers.jobs/northbrook-il/associate-director-pharmacometrics/417F851575CD44969065DFF6EDAF23A5/job/
Purpose & Scope:
* Provide scientific, technical, and strategic
pharmacokinetic-pharmacodynamic modeling and simulation (M&S) support within
and across TAs
* Creation of scientific reports to document modeling activities and
support registration
* Writing of regulatory documents and interaction with regulatory agencies
* May act as a Clinical Pharmacology core team member and leading Clinical
Pharmacology Extended Teams
Essential Job Responsibilities:
* Perform pharmacokinetic-pharmacodynamic modeling and simulation using a
variety of software, which may include NONMEM, R, and SAS
* Peer review of M&S reports and analyses
* Make summaries and presentations of analyses to others
* Manage and oversee outsourced projects
* Contribute to the design, analysis, and reporting of clinical studies
for a compound and to provide M&S input to the clinical development strategy
* Act as the M&S representative on Core Teams, Extended Teams, Early
Modeling Teams, and the Quantitative Quartet
* Be actively involved in strategic modeling discussions with other
pharmacometricians, and PBPK and QSP modelers
* Represent M&S for in-house discovered or in-licensed compounds, which
may include Due Diligence activities
* Preparation of various sections of regulatory documents, such as IB,
IND, and CTD,, and interaction with regulatory agencies
* May lead various working groups or initiatives to improve internal
processes or best practices
* Maintain knowledge of a particular disease area and M&S in general to
ensure availability of state-of-the art knowledge and experience in
pharmacometrics for practical application in clinical development
* Mentoring of junior M&S scientists
* May act as a Clinical Pharmacology core team member and leading Clinical
Pharmacology Extended Teams
Quantitative Dimensions:
* Responsible for the design, analysis, and reporting of all M&S analyses
associated with 3 to 10 projects per year with 1 to 4 projects at any given time
* Responsible for management of timelines of M&S analyses related to
particular studies
* Responsible for management of costs and timelines of outsourced M&S
analyses
* May coach 1 to 2 new staff members on company and project team related
procedures within Pharmacometrics and CPED
* Responsibilities may directly impact on strategy and efficiency of
clinical development of compounds
* May create 10 to 25 modeling reports per year
* The position has no direct budget responsibility
Organizational Context:
* This position reports to the Pharmacometrics US Group Lead, Stacey
Tannenbaum
* This position has no direct reports
* Direct interaction with the Quantitative Quartet (clinical, statistics,
clinical pharmacology science), extended CPED team members, and core team
partners
Qualifications:
* Advanced degree MD/ PhD /PharmD required
* Requires at least 5 years post-graduate PhD experience or 9 years
post-MS in the pharmaceutical industry with a good understanding of drug
discovery and development
* Ability to integrate knowledge across all CPED functions
* Theoretical and working understanding of modeling and simulation of
pharmacokinetic- pharmacodynamic data
* Through understanding of pharmacokinetic-pharmacodynamic principles and
how they are applied to clinical pharmacology
* Basic understanding of disease biology and exposure-response M&S
required to design early development strategies up to and including PoC
* Expert working and theoretical knowledge of population
pharmacokinetic-pharmacodynamic modeling methodologies and software
* Working knowledge of Microsoft Office
* Working knowledge with graphics software or tools
* Working knowledge of a programming language such as SAS or R
* Working understanding of regulatory strategies and guidelines
* Experience in regulatory filings, eg., IND, IMPD, NDA, etc, and
interactions with regulatory authorities worldwide
* Good written and communication skills
* Strong, critical analytical mind
* Ability to operate with minimum of supervision
Stacey Tannenbaum, PhD, FISoP
Senior Director, Pharmacometrics US
Clinical Pharmacology and Exploratory Development
Astellas Pharma, Northbrook, IL
[email protected]<mailto:[email protected]>
Tel: 224-205-5038
Cell/Mobile: 847-830-1598
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