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Clin Pharm Director

From: TJ Elder <telder>
Date: Thu, 5 Mar 2020 13:58:42 +0000

The Director level clinical pharmacologist/pharmacokineticist in the Depart=
ment of Translational Medicine and Early Stage Clinical Development plays a=
 central role in both clinical development and in support of nonclinical de=
velopment. He/she will represent Clinical Pharmacology function and provide=
 subject matter expertise on cross-functional project teams. He/she will me=
ntor junior and senior level scientists in the department in addition to be=
ing an individual contributor.
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 Director role supports multiple programs =
through participation on internal project teams and serves as a liaison bet=
ween chemistry, life sciences, regulatory and clinical operations. Essentia=
l Areas of Responsibility: The incumbent may design, conduct and/or manage =
internal and external IND-enabling studies (eg: in vitro and in vivo noncli=
nical metabolism and PK), design and review clinical pharmacology study pro=
tocols and support clinical trials, conduct pharmacokinetic/pharmacodynamic=
 modeling and analyses, and incorporate findings into study report and regu=
latory documents as well as participate directly in regulatory interactions=
. A strong background in clinical pharmacology and pharmacokinetics combine=
d with excellent leadership and communications skills are essential in this=
 dynamic role. Clinical pharmacology experience with both small and large m=
olecules in a variety of clinical investigation paradigms (eg: adaptive tri=
al design) is desired. Direct experience with pharmacokinetic/pharmacodynam=
ic modeling, bioanalytical analysis, and nonclinical ADME are desirable att=
ributes. Knowledge of, and immediate experience in the area of CNS and/or o=
ncology therapeutics is desired.
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 10+ years of experience in pharmaceutical industry. Demonstrated e=
xperience in serving as clinical 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.
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.
Excellent interpersonal, leadership, communication and time-management skil=
ls are essential; demonstrated direct management of internal and external p=
ersonnel (outsourced projects) is required.

TJ Elder
Search Consultant
Pre-Clinical Development
O: 413.458.6124
C: 413.207.7676


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Received on Thu Mar 05 2020 - 08:58:42 EST

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