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Exciting Director of Modeling and Simulations opening!

From: TJ Elder <telder>
Date: Tue, 28 Jul 2020 15:13:52 +0000

Director in Modeling & Simulations will combine strong pharmacometric skill=
s with a deep biological understanding. They are responsible for independen=
tly determining, planning, and executing M&S analyses for an entire drug de=
velopment program in close collaboration with cross-functional colleagues w=
ithin the R&D organization. Specific experience and interest in working in =
population PK/PD or quantitative systems pharmacology is required. The Dire=
ctor determines, plans, and executes technically challenging analyses by us=
ing state of the art Modeling & Simulation methodologies to strongly contri=
bute to critical decision making. The Director will lead M&S projects for a=
n entire drug development program to evaluate study design, dose selection,=
 probability of success estimation, portfolio strategy, pediatric extrapola=
tion etc. In this role, it is expected that they will represent M&S with cr=
oss-functional drug development teams, proactively advocate for model-based=
 approaches, and clearly communicate M&S results.

KEY RESPONSIBILITIES:

Independently determines, plans, executes, and interprets modeling analyses=
 for an entire drug development program aligned with the program strategy
Closely collaborates with the Modeling & Simulations senior director
Represents M&S on cross-functional drug development teams, proactively advo=
cating model-based approaches to address development challenges
By using state of the art Modeling & Simulation methodologies strongly cont=
ribute to decision making at critical milestones based on quantitative prin=
ciples in close collaboration with Biostats, Clin Pharm and other quantitat=
ive disciplines
Represents M&S in preparation for regulatory responses and external regulat=
ory interactions
Represents the department in company-wide, non-scientific initiatives
Proactively incorporates and develops approaches and methodologies based on=
 review of relevant scientific literature
Supervise and mentor junior scientists
Perform population PK, PKPD-analyses, Clinical trial simulations and other =
model based analyses on a regular basis
Coordinate outsourced Modeling & Simulation activities when appropriate
Strengthen our internal Modeling & Simulation capability on a continuous ba=
sis by initiating training activities, evaluating and incorporating new M&S=
 tools as appropriate.
Demonstrate effective communication and leadership to a broad audience with=
 diverse backgrounds, including senior management
PREFERRED EDUCATION AND EXPERIENCE:

PhD in Pharmaceutics, Clinical pharmacology, or other quantitative discipli=
ne with an emphasis Pharmacometric methodologies
Minimum of 10+ yrs of industry experience in the application of Pharmacomet=
rics within the context of drug development.
Expert hands-on skills from population-based PKPD modeling, Clinical trial =
simulation and optimal design, probability of success calculations, Disease=
 progression modeling, Meta analyses etc.
A solid understanding of fundamental pharmacokinetic and quantitative pharm=
acology (PKPD) principles.
Excellent programming skills (NonMem, R, Phoenix, SAS and other similar too=
ls)
Demonstrated strong leadership- and influencing skills
Excellent collaborative, verbal and written communication skills
Experience from Regulatory interactions and guidelines relevant for M&S


For more information please contact:

TJ Elder
Search Consultant
Pre-Clinical Development
O: 413.458.6124
C: 413.207.7676
https://www.linkedin.com/in/tjelder/
telder


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Received on Tue Jul 28 2020 - 11:13:52 EDT

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