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FW: Senior Scientist, Clinical Pharmacology/Pharmacometrics - Biogen, US-MA-Cambridge

From: Ivan Nestorov <ivan.nestorov>
Date: Fri, 18 May 2018 12:28:13 +0000

Associate Director - Pharmacometrics



The Associate Director of Pharmacometrics serves as the quantitative pharma=
cology and pharmacometrics lead on early clinical development teams providi=
ng strategic leadership and execution of development plans that include adv=
anced quantitative characterization and prediction of the pharmacokinetics,=
 pharmacodynamics and drug metabolism (PPDM) of the drug candidate.

Job Category

Research & Development

Requisition Number


Job Description

This person also provides quantitative rationale for dose regimen selection=
, safety margin assessment and identification of circumstances where dose a=
djustment or patient selection/stratification should be considered. This pe=
rson is expected to engages in cross-functional activities providing Quanti=
tative Pharmacology and Pharmacometric input and scientific opinion to othe=
r groups and departments and line management. With minimum supervision driv=
es the development and execution of the Quantitative Pharmacology and Pharm=
acometric Strategy of clinical development teams. Advises teams on Quantita=
tive Pharmacology and Pharmacometric Strategy and science and provides inpu=
t to line management. Works with study and clinical development teams to ac=
hieve program goals and provide deliverables in approved timeframes. Develo=
ps and maintains scientific awareness and presence in Quantitative Pharmaco=
logy and Pharmacometric Science, publishes manuscripts and posters, present=
s at Scientific Conferences and other scientific forums. Leads advanced qua=
ntitative pharmacology and pharmacometric analyses and activities within as=
signed programs to yield high value PK/PD support for critical decisions. I=
nterprets and presents results and recommends appropriate actions. With min=
imum oversight provides insightful regulatory strategy for Quantitative Pha=
rmacology and Pharmacometric support of drug filings and is responsible for=
 the respective sections of regulatory documents. Develops and maintains st=
rong knowledge of best regulatory practices, PK/PD analysis methodology and=
 drug development precedent.


Demonstrates a strong understanding of: 1) Advanced data analysis and simul=
ation methodologies 2) PK/PD principles, physiology/pharmacology and pathol=
ogy; 3) operational and scientific aspects of early development studies. Em=
ploys continuous improvement in knowledge and practical understanding of PP=
DM, Clinical Pharmacology and application of this knowledge in the program =
team setting. Understands and is able to apply appropriate regulatory and I=
CH guidelines in the design of all studies. Can manage a diverse, time-sens=
itive workload. Has excellent organizational and interpersonal skills. Some=
 experience in drafting early drug development strategy and designing/imple=
menting studies for multiple compounds including PPDM data analyses for bot=
h biologics and small molecules.


Ph.D., M.D./Ph.D., or Pharm.D. in pharmacy, applied pharmacology, pharmacok=
inetics, biomedical engineering, biostatistics, or a related field. 5+ year=
s of direct industry experience in preclinical and clinical pharmacology, m=
odeling & simulation, and program team support.
Please, apply at<> or email<


Ivan Nestorov, PhD
Sr. Director, Pharmacometrics
Biogen Inc
225 Binney Street
Cambridge, Massachusetts 02142
Tel: 617-679-2541
Email: ivan.nestorov

Received on Fri May 18 2018 - 08:28:13 EDT

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