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Director Pharmacometrics US at Astellas we are hiring

From: Bauer, Robert <Robert.Bauer>
Date: Mon, 16 Aug 2021 21:54:46 +0000

Submitted on behalf of Stacey Tannenbaum:

Pharmacofriends and colleagues,

We are looking for a Director level Pharmacometrician for our team at Astel=
las.   Come work with me and an amazing group of scientists worki=
ng on exciting drug development projects

We are open to remote work within the continental US.   Copy/past=
e this link into your browser ( and/or feel=
 free to reach out to me directly at Stacey.tannenbaum

Purpose & Scope
Provide scientific, technical, and strategic pharmacokinetic-pharmacodynami=
c modeling and simulation (M&S) support within and across therapeutic areas
Creation, review, and approval of scientific reports to document modeling a=
ctivities and support registration
Writing of regulatory documents and interaction with regulatory agencies
May have mentoring/coaching or supervising responsibilities

Essential Job Responsibilities
Perform pharmacokinetic-pharmacodynamic modeling and simulation using a var=
iety 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 provide M&S input to the clinical development strategy
Act as the M&S representative on Core Teams, Extended Teams, Early Modeling=
 Teams, and Quantitative Quartet
Be actively involved in strategic modeling discussions with other pharmacom=
etricians, and PBPK and QSP modelers
Represent M&S for in-house discovered or in-licensed compounds, which may i=
nclude Due Diligence activities
Preparation of various sections of regulatory documents, such as IB, IND, a=
nd CTD, and interaction with regulatory agencies
May lead various working groups or initiatives to improve internal processe=
s or best practices
Maintain knowledge of a particular disease area and M&S in general to ensur=
e availability of state-of-the art knowledge and experience in pharmacometr=
ics for practical application in clinical development
Mentoring of junior M&S scientists
May act as a Clinical Pharmacology core team member and leading Clinical Ph=
armacology Extended Teams
Contribute to the definition, implementation and maintenance of new multidi=
sciplinary ways of working in order to improve the efficiency and effective=
ness of the Pharmacometrics group and CPED
Display leadership attributes that lead to the improvement of Pharmacometri=
cs and CPED processes and level of science
Contribution to and review of scientific, strategic, and technical document=
s produced by the Pharmacometrics Group

Quantitative Dimensions
Responsible for the design, analysis, and reporting of all M&S analyses ass=
ociated with ~3 to 10 projects per year with ~1 to 4 projects at any given =
Responsible for management of timelines of M&S analyses related to particul=
ar studies
Responsible for management of costs and timelines of outsourced M&S analyse=
May coach 1 to 2 new staff members on company and project team related proc=
edures within Pharmacometrics and CPED
Responsibilities may directly impact on strategy and efficiency of clinical=
 development of compounds.
May create and/or review 10 to 25 modeling reports per year for scientific =
and technical quality
The position has no direct budget responsibility

Organizational Context
This position reports to the Pharmacometrics US Group Lead
May have functional management of scientists
Direct interaction with the Quantitative Quartet (clinical, statistics, cli=
nical pharmacology science), extended CPED team members, and core team part=

Required Qualifications:
Advanced degree MD/ PhD /PharmD/MS required
Requires at least 8 years post-graduate PhD/MD experience or 12 years post-=
MS in the pharmaceutical industry with a solid understanding of drug discov=
ery and development
Can integrate knowledge across all CPED functions
Theoretical and working understanding of modeling and simulation of pharmac=
okinetic- 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 t=
o design early development strategies up to and including PoC
Expert working and theoretical knowledge of population pharmacokinetic-phar=
macodynamic modeling methodologies and software
Working knowledge of Microsoft Office
Working knowledge with graphics software or tools
Expert working knowledge of a programming language such as SAS or R
Thorough understanding of regulatory strategies and guidelines
Experience in regulatory filings and interactions with regulatory authoriti=
es worldwide preferred
If this is a line management role, personnel management experienced highly =
Demonstration of strategic thinking related to pharmacokinetic-pharmacodyna=
mic exposure- response analyses and pooled analyses across a project
Good written and communication skills
Strong, critical analytical mind
Ability to operate with minimal supervision
Strong leadership skills

Stacey Tannenbaum, PhD, FISoP
Senior Director, Pharmacometrics US
Clinical Pharmacology and Exploratory Development
Astellas Pharma, Northbrook, IL
Tel: 847-830-1598 <br /><br /> ICON plc made the following annotations.=

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Received on Mon Aug 16 2021 - 17:54:46 EDT

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