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Remote Pharmacometrics opportunity

From: TJ Elder <telder>
Date: Fri, 21 May 2021 12:39:37 +0000

Our Client is seeking the role of Associate Director/Director Clinical Phar=
macologist/Pharmacokineticist in the Department of Translational Medicine a=
nd Early Stage Clinical Development plays a central role in both clinical d=
evelopment and in support of nonclinical development. He/she will represent=
 Clinical Pharmacology function and provide subject matter expertise on cro=
ss-functional project teams. He/she will assist in directing the clinical p=
harmacology development plan, synopsis preparation, clinical phase oversigh=
t, and reporting, and provide leadership of a multifunctional study team fo=
cused on clinical studies through design, delivery, and reporting, as well =
as ensuring scientific accountability. He/she will mentor junior and senior=
 level scientists in the department in addition to being an individual cont=
ributor.

A core scientific responsibility is ensuring optimal doses and dosage regim=
ens in patients, and as such, the successful candidate must be able to inte=
grate the knowledge of PK/PD, quantitative modeling and simulation, drug de=
velopment, TK, and nonclinical PK (ADME and DMPK). Working within the clini=
cal development organization, the role supports multiple programs through p=
articipation on internal project working teams and serves as a liaison betw=
een chemistry, life sciences, regulatory and clinical operations. Essential=
 Areas of Responsibility: The incumbent may design, conduct and/or manage i=
nternal and external IND-enabling studies (eg: in vitro and in vivo nonclin=
ical metabolism and PK), design and review clinical pharmacology study prot=
ocols and support clinical trials, conduct pharmacokinetic/pharmacodynamic =
modeling and analyses, and incorporate findings into study report and regul=
atory documents as well as participate directly in regulatory interactions.=
 A strong background in clinical pharmacology and pharmacokinetics combined=
 with excellent leadership and communications skills are essential in this =
dynamic role. Clinical pharmacology experience with both small and large mo=
lecules in the area of oncology/immuno-oncology therapeutics is highly desi=
red. Knowledge of, and direct experience with pharmacokinetic/pharmacodynam=
ic modeling, bioanalytical analysis, and nonclinical ADME are desirable att=
ributes.

The candidate is expected to be an active contributor to the multi-discipli=
nary project teams, providing innovative and progressive thinking to projec=
ts and where appropriate guidance to other team members. Upon completion of=
 on-boarding, this person will be relied upon to act independently, within =
a highly matrixed clinical development organization and must have the exper=
ience and conviction to provide sound clinical pharmacology related input t=
o the project teams.


Minimum Education & Experience Requirements:

Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related fi=
eld with 6+ years (Associated Director) or 10+ years (Director) of experien=
ce in pharmaceutical industry. Demonstrated experience in serving as clinic=
al pharmacology lead on development programs.
Experience in non-compartment and model-based PK and PK/PD analyses and inc=
lusion of data in the preparation of manuscripts, study reports and section=
s of regulatory submission documents (eg: INDs, NDAs, CTDs) is required.
The incumbent should have a strong understanding of pharmacokinetic theory,=
 compartmental modeling and simulation, and statistical approaches utilizin=
g the latest computational approaches and tools
Hands-on experience in utilizing WinNonLin, NONMEM and/or other modeling so=
ftware is required. Experience with population PK, mechanistic PK-PD modeli=
ng/systems pharmacology and PBPK modeling is a plus. Familiarity with stati=
stical approaches and programs for data analysis.
Scientific writing and presentation skills are essential; peer reviewed pub=
lications in a relevant field required.
Current knowledge of FDA regulatory guidance related to nonclinical and cli=
nical pharmacology; experience having direct interaction with FDA, includin=
g submission of IND, NDA and other regulatory documents is required.
Understanding of, and compliance with, regulatory, protocol, standard opera=
ting procedures, and Good Laboratory Practices (GLP) and Good Clinical Prac=
tices (GCP) as appropriate.
Demonstrated direct management of internal and external personnel (outsourc=
ed projects) is required.

For more information please contact:

TJ Elder
President
O: 413.458.6124
C: 413.207.7676
https://www.linkedin.com/in/tjelder/
telder


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Received on Fri May 21 2021 - 08:39:37 EDT

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