[NMusers] Pharmacometric Job in Biogen, Cambridge, MA

From: Ivan Nestorov <ivan.nestorov_at_biogen.com>
Date: Thu, 3 Aug 2017 15:46:13 +0000

Posting Title:

Associate Director, Pharmacometrics, Clinical Pharmacology and Pharmacometr=
ics Group


Job Description:

The Associate Director, Pharmacometrics, Clinical Pharmacology and Pharmaco=
metrics Group, serves as the Clinical Pharmacology and Pharmacometrics lead=
 on early program teams providing strategic leadership and execution of Qua=
ntitative Pharmacology plans that include characterization of the Pharmacok=
inetics, Pharmacodynamics and Drug Metabolism (PPDM) of the drug candidate.=
 This person also executes and/or oversees development and application of Q=
uantitative models, providing rationale for dose regimen selection, safety =
margin assessment and identification of circumstances where dose adjustment=
 should be considered.


* Responsible for providing key components of the Early Development=
 Plan (strategy/analysis through final reports) and for providing input and=
 scientific opinion to project teams, line management, and governance bodie=
s.

* Leads Clinical Pharmacology and Pharmacometrics study efforts (eg=
, study design, protocol concepts/protocols preparation, clinical phase ove=
rsight, and reporting) within assigned programs to yield high value PK/PD/D=
M insight for future critical decisions. Analyzes results, interprets, and =
recommends action based on study results.

* Works with Clinicians, Quantitative Sciences and DMPK/PD to ensur=
e appropriate study designs are achieved for successful implementation of d=
ata analyses and accomplishment of intended study outcomes.

* Works with study and program teams to achieve program goals and p=
rovide deliverables in approved timeframes.

* Identifies program and study-specific issues. Generates potential=
 solutions to issues and proposes those solutions to management and/or stud=
y teams.

* Utilizes Advisory Board members, Thought Leaders, and Academic Co=
llaborators as necessary to add effective value to our development programs=
.

* Develops and maintains strong knowledge of best regulatory practi=
ces, analytical technology and drug development precedent for Clinical Phar=
macology and Pharmacometrics.

* Provides regulatory strategy and is responsible for Clinical Phar=
macology and Pharmacometrics sections of regulatory documents.


Qualifications:


* Employs continuous improvement in knowledge and practical underst=
anding of Mechanistic/Systems Pharmacology, PPDM, Clinical Pharmacology and=
 Pharmacometrics and application of this knowledge in the program team sett=
ing.

* Understands and is able to apply appropriate regulatory and ICH g=
uidelines in the design of all studies.

* Can manage a diverse, time-sensitive workload.

* Possesses strong English communication skills requiring minimal o=
versight in drafting grammatically correct written documents and making ora=
l presentations.

* 4+ years of direct industry experience in Clinical Pharmacology a=
nd Pharmacometrics , advanced modeling & simulation, and program team suppo=
rt.

* Some experience in drafting early drug development strategy and d=
esigning/implementing studies for multiple compounds including PPDM data an=
alyses for both biologics and small molecules.

* Demonstrates a strong understanding of: 1) PK/PD principles, phys=
iology/pharmacology and pathology; 2) operational and scientific aspects of=
 early development studies; and 3) quantitative analysis.



Qualifications:

Ph.D., M.D./Ph.D., or Pharm.D. in biomedical engineering, applied pharmacol=
ogy, statistics, pharmacokinetics, or a related field.

If interested; Please send resume to Isaac Blum at Isaac.Blum_at_Biogen.com<ma=
ilto:Isaac.Blum_at_Biogen.com> or Ivan Nestorov at ivan.nestorov_at_biogen.com<ma=
ilto:ivan.nestorov_at_biogen.com>



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



Received on Thu Aug 03 2017 - 11:46:13 EDT

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