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Clinical Trial Simulation Expert

From: Barrett, Jeffrey <BARRETTJ>
Date: Fri, 29 May 2015 16:30:40 +0000

Dear Friends and specifically those experienced in clinical trial simulatio=

Are you willing to make a change to do something exciting? Help create a cl=
imate for innovation and join the ranks of informed decision makers at Sano=
fi. We need you! This is an exciting opportunity for the right person. The =
details of the position are provided below but I'm happy to explain further=
 for those who are qualified and interested. I'll be at the PAGE meeting . =
. . find me :)


(contact via email is fine as well :) )

Vice-President, Interdiciplinary Pharmacometrics Program

Global Head, Pediatric Clinical Pharmacology


Senior Clinical Trial Simulation Expert (Senior Director)
Summary of Role:
The position of Senior Clinical Trial Simulation (CTS) Expert is a highly i=
nfluential leadership role within Early and Late Development, Clinical R&D.=
 This scientific and highly technical role provides a unique opportunity to=
 set-up, develop and lead the field of clinical trial simulation across the=
 global organization. The appointee will be responsible for all CTS (includ=
ing pharmacokinetics and PK/PD) aspects of global projects at the early cli=
nical stage (phase I) as well as those across all later clinical stages (Ph=
ase II post-marketing) at Sanofi. The industry-experienced person under=
taking this role will have strong and proven statistical and specifically c=
linical trial simulation knowledge, with demonstrable modelling and simulat=
ion skills, and will work in close collaboration with various non-clinical,=
 Research, and Clinical R&D functions. The appointee will be required to en=
sure provision of CTS support to all R&D projects through the use of intern=
al resources and external alliances, though undertaking hands-on modelling =
and simulation work on selected crucial projects will also be a requirement=
This role will report to the Global Head of Biostatistics within Clinical S=
cience & Operations (CSO) and will work alongside the Global Head of the In=
terdisciplinary Pharmacometrics Program (IPP), to lead and implement the CT=
S strategy for the portfolio. This role will also collaborate with project =
statisticians and / or pharmacometricians serving at a project and/or a stu=
dy levels for CTS projects and will also coordinate interactions with senio=
r-level external consultants or with academic institutions.

Lead the implementation of CTS strategies in all global R&D projects as=
 appropriate. Apply these strategies at a therapeutic area, as well as proj=
ect, level.
Implement all necessary hardware and software systems, together with re=
levant quality processes, for the conduct of in-house CTS activities.
Lead the planning and execution of all relevant pharmacometric analyses=
: non-compartmental PK, PK/PD analyses, population PK and PK/PD, modelling =
and simulation methods, meta-analyses, disease and systems biology modellin=
Ensure the use of innovative analytical methods in pharmacometrics/mode=
lling and simulation to integrate knowledge of pharmacokinetics, pharmacody=
namics, patient characteristics and disease states in support of optimal st=
udy designs and CTS.
Provide statistical contributions to regulatory documents including Inv=
estigator Brochures, Labelling and those required for regulatory meetings a=
nd regulatory filings. Provides resolution of biostatistical and/or pharmac=
ometrics queries from regulatory agencies as necessary.
Writes, or leads the writing of, relevant sections of clinical study pr=
otocols, statistical analysis plans, and clinical study reports. Provides i=
nput for, or leads derivation of, standard operation procedures and best pr=
actices in biostatistics and/or pharmacometrics.
Develop external alliances with consultants, contract organizations and=
 academic institutions to ensure timely conduct of all pharmacometrics deli=
verables for projects, to continually keep abreast of the science, as well =
as development of more junior colleagues in the discipline.
Input to licensing projects as needed.

 Essential Qualifications/Experience:
Ph.D. in Statistics/Biostatistics (or equivalent statistical M&S experience=
) with demonstrated expertise in CTS and strong quantitative skills.
Essential experience
A minimum of 15 years of pharmaceutical industry (or relevant) experien=
ce, specifically contributing to CTS aspects of clinical drug development.
Significant experience in the design and analysis of clinical trials
Thorough understanding of pharmacokinetics, PK/PD, population and model=
ling & simulation methodologies with related data interpretation, and gener=
al clinical pharmacology (including the design and conduct of clinical tria=
Ability to effectively collaborate, communicates, and influence through=
out all levels of the organization.
Strong leadership abilities

Essential Skills, Knowledge & Attributes:
Functional scientific knowledge, including:
Essential Advantageous
- In-depth knowledge and experience in advanced PK and PK/PD - Clinical pha=
rmacology methods
- Working knowledge and experience of software such as NONMEM, SAS, Monolix=
, and other server-based data processing and modelling tools - Programming =
experience with R or C++
- Knowledge of the role of pharmacometrics in drug development and FDA/ICH =
requirements for drug registration - Experience in endpoint modelling and d=
isease progression modelling
- Knowledge and application of statistics, random effects modelling, mixed =
effects modelling, data mining, population PK/PD analyses and modelling (in=
cluding nonlinear models), Bayesian methods, clinical utility indices, and =
Monte-Carlo simulation - Interpretation of basic, safety pharmacology and t=
oxicology data
- Clinical trial design and simulation
- PK and PD drug interactions, in vivo/in vitro models
- Biopharmaceutics
- Participation in full clinical pharmacology programs and in-depth underst=
anding of full clinical development

Regulatory and Quality Systems
Representation and pharmacometrics leadership at regulatory authority m=
IND, CTA submissions
ICH Good Clinical Practice and Good Laboratory Practice
EMEA and FDA guidelines
Quality Control systems and processes for data analytical work to meet =
Regulatory requirements
In-depth knowledge of, and experience with global biostatistics and pha=
rmacometrics regulatory requirements

Communication and Interpersonal
Excellent communication skills with demonstrated ability to effectively=
 present any aspect of this highly technical field, as well as its plans/st=
rategies, accordingly to various audiences in both verbal and written form.
Proven ability to lead and mentor more junior statisticians and pharmac=
Excellent oral presentation skills.
Ability to provide leadership in this discipline within the organizatio=
Ability to create and communicate statistical and pharmacometrics plans=
Ability to create publications according to international scientific st=
Good interpersonal skills, including a positive and constructive attitu=
de and ability to effectively work in a team matrix environment. Negotiatio=
n and influential skills advantageous.
Experience working in multifunctional teams and ability to work collabo=
ratively within matrix management environment.

Received on Fri May 29 2015 - 12:30:40 EDT

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