[NMusers] ACoP10: Clinical Pharmacology and Pharmacometrics Opportunities at GlaxoSmithKline

2019-10-20 Thread Mindy Magee 
Dear ACoP10 attendees,

Clinical Pharmacology Modeling & Simulation department at GlaxoSmithKline is 
experiencing healthy expansion in number and impact to drive the success of GSK 
portfolio in multiple therapeutic areas from early phase preclinical to 
clinical translation to proof of concept to late phase submissions in 
end-to-end clinical development.

We are looking for quantitative clinical pharmacologists to join our global 
department in multiple therapeutic areas in the Collegeville, PA location. If 
you are interested in learning more, please meet me at ACoP in Orlando 
([email protected] or 484-995-2756).

Regards,
Mindy Magee

Clinical Pharmacology Modeling and Simulation
Clinical Pharmacology Experimental Medicine

GSK
1250 S Collegeville Rd, Collegeville, PA 19426 United States
Email   [email protected]
Tel   +1 484-995-2756

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[NMusers] ACoP10: QSP and Clin Pharm Opportunities at Pfizer

2019-10-19 Thread Nucci, Gianluca 
Dear all,

Pfizer is a leader in MIDD and our Early Development team - combining world 
leading talents in both QSP and quantitative Clinical Pharmacology - is growing 
in number and influence across multiple therapeutic areas and locations.

We are looking for Clinical Pharmacology Lead as well as QSP Lead candidates 
with different roles and levels of experience.

For more information come see CJ Musante ([email protected]) or 
myself ([email protected]) at ACoP in Orlando.

Best Wishes,

Gianluca
Gianluca Nucci, PhD
ECD Clinical Pharmacology Head
Pfizer Worldwide Research & Development
1 Portland St, Cambridge, MA 02139

[NMusers] ACoP10 - Certara is hiring!

2019-10-18 Thread Colette Anderson 
Do you want to make a REAL impact in drug development and patient care 
decision-making?  Do you want the opportunity to work with hundreds of global 
biopharmaceutical companies, leading academic institutions, and key regulatory 
agencies worldwide?

If so, come visit the Certara team at ACoP10 to learn how we are optimizing 
drug development decisions and how you can be part of it:


  *   Help create the science and technology decision-support platform for 
transforming drug development and patient outcomes.
  *   Deepen your skills working alongside experts in the fields of 
Pharmacometrics and Clinical Pharmacology.
  *   Broaden your therapeutic expertise by supporting a myriad of companies 
and drug development programs.

We are hiring Associate Director, Director and Senior Director level 
Pharmacometricians & Clinical Pharmacologists in North America, Europe and 
Japan!   Many of our opportunities allow for flexible remote based work, so 
being in an office is not required.  If you want to work in an office, we have 
locations throughout North America, in many countries across Europe and in 
Japan.

Certara has assembled a diverse team-including thought leaders in model-based 
drug development, regulatory science, and the use of informatics, advanced 
technology, and real-world evidence to inform key drug development decisions 
-whose members are among the most well-respected in our industry. Our employees 
bring decades of experience to our clients and embody a culture of 
accountability, collaboration, mentorship, and growth. If working alongside 
smart and driven colleagues sounds exciting to you, we want you on our team!

If you are interested in an exciting and cutting edge career with Certara, 
please come to our booth at ACoP10, visit our Careers Page at 
www.certara.com/contact-us/careers 
or send your CV to [email protected].


Colette Anderson, PHR, SHRM-CP
HR Operations Director
[cid:[email protected]]
Phone: +1 609 937 9940
[email protected]


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[NMusers] ACoP10

2019-10-17 Thread Hughes & Associates 
Dear All,



*We will be at ACoP10 next week and would love to catch up to discuss your
career goals! Schedule a meet-up today!*


Hughes and Associates is currently recruiting for multiple new
opportunities in clinical pharmacology and pharmacometrics. Our top clients
are located throughout the US and abroad. These opportunities range from:

Scientist

Sr. Scientist

Associate Director

Director

Sr. Director

VP


US-based opportunities are located in the Northeast, Bay Area, San Diego,
and Midwest.

If you would like to discuss these opportunities contact Jay Chapman at
[email protected], 704.333.5213.


Hope to see you soon,


The Hughes and Associates team

[NMusers] ACoP10 Post-Meeting Workshop: Integration of PHM and Stat Analyses Using CTS, October 24, 2019

2019-06-10 Thread Ken Kowalski 
Dear NMUsers,

 

On Thursday, October 24, 2019, I will be giving an ACoP10 post-meeting
workshop in Orlando, FL.  This workshop will be a 3-hour didactic lecture
based on my recently published paper:

 

Kowalski, K.G. "Integration of Pharmacometric and Statistical Analyses Using
Clinical Trial Simulations to Enhance Quantitative Decision Making in
Clinical Drug Development".  Statistics in Biopharmaceutical Research
2019;11:85 - 103.

 

See below for a description of the workshop.  To register for the workshop
please visit the ACoP10 registration website:
https://www.go-acop.org/workshops-at-acop

 

I hope to see you there.

 

Best,

 

Ken

 

Kenneth G. Kowalski

Kowalski PMetrics Consulting, LLC

Email: [email protected]  

Cell:248-207-5082

 

Integration of Pharmacometric and Statistical Analyses using Clinical Trial
Simulations to Enhance Quantitative Decision Making in Clinical Drug
Development

 

Workshop Description

This workshop outlines a general framework in which clinical trial
simulations are employed integrating both pharmacometric and statistical
analyses to support trial design and quantitative decision making in drug
development.  Specifically, predictive pharmacometric models are used as
data-generation models to simulate data, while data-analytic models as
specified in the statistical analysis plan are used to analyze the simulated
data, and to apply a quantitative data-analytic decision rule.  Various
probability metrics including probability of achieving the target value
(PTV), probability of success (POS), and probability of a correct decision
(POCD) are proposed to support study design recommendations and quantitative
decision-making.  A case study is presented to illustrate the clinical trial
simulation methods and procedures described in this article.

 

Training Objectives

1. Learn how to formulate quantitative decision rules using confidence
interval criteria.

 

2. Understand the concept of assurance or probability of success and how
it differs from statistical power.

 

3. Understand the distinction between confidence intervals and
prediction intervals and how to perform stochastic simulations using
pharmacometric models to construct such statistical intervals.

 

4. Learn how to apply clinical trial simulation procedures to evaluate
various probability metrics including PTV, POS, and POCD to support study
design recommendations and quantitative decision-making.

 

 



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