[NMusers] Senior / Principal Clinical Pharmacokineticist (Mountain View, CA/South San Francisco)

From: Ly, Neang <lyn_at_MedImmune.com>
Date: Mon, 24 Apr 2017 16:35:51 +0000

Senior / Principal Clinical Pharmacokineticist - Clinical Pharmacology, Pha=
rmacometrics & DMPK
Location-Mountain View, CA/South San Francisco CA

If you're inspired by the possibilities of science to change lives and you =
thrive when making brave decisions - join us.
MedImmune is the worldwide biologics research and development arm of AstraZ=
eneca. Here, you'll have the opportunity to make a difference in people's l=
ives every day. As one of the world's premier biotechnology companies, our =
mission is centered on delivering life-changing products that advance world=
 health, and help fight and cure disease. As a Senior Clinical Pharmacokin=
eticist or Principal Clinical Pharmacokineticist in Mountain View, CA, yo=
u'll play a pivotal role in channeling our scientific capabilities to make =
a positive impact on changing patients' lives.
And we're excited to share that our work at the Mountain View site (along w=
ith some other AstraZeneca Group Companies in the Bay Area) will relocate t=
o South San Francisco by end of 2017. Click here<https://www.astrazeneca-u=
ornia-with-new-south-san-francisco-location-09272016.html> for more informa=
tion on this new facility.
We're constantly pushing the boundaries of science to deliver life-changing=
 medicines to patients, with a passion for discovery and a pipeline to show=
 for it. We're pioneering innovative research and exploring novel pathways =
across key therapeutic areas including oncology, respiratory, inflammation =
and autoimmunity, cardiovascular and metabolic disease, and infection and v=
accines. And we're industry-leading in immunology, protein engineering and =
translational science. We offer a unique and strong collaborative network a=
s part of the AstraZeneca family, as together we explore synergies between =
small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovati=
on. We attract top minds, and we nurture and build top talent.

Main Duties and Responsibilities
You will function as the global Clinical Pharmacology/DMPK (CPD) team repre=
sentative for biotherapeutic projects at various stages of research and dev=
elopment (target validation through life-cycle management) and be responsib=
le for all aspects of pharmacokinetic/pharmacodynamics (PKPD) -related supp=
ort for biotherapeutic products, including design of studies, analysis and =
reporting of data, and communication of data in regulatory documents and me=
etings. You will also be responsible for providing clinical pharmacology e=
xpertise into clinical development plans, including the design, conduct and=
 interpretation of relevant clinical pharmacology studies, including PKPD s=
tudies, analysis of data using complex PKPD modelling and simulation method=
ologies, development and delivery of regulatory strategy (e.g IB/IND, end o=
f phase 2, and BLA) etc, and data analysis and reporting of clinical studie=
Additionally, you will function as the sole point of contact for all CPD ac=
tivities on projects at all stages of discovery and development and be able=
 to influence team strategy using modelling expertise; Be pivotally involv=
ed in assessing and managing analyses of PK/PD data, integrating clinical t=
rial simulation strategies and disseminating the clinically relevant risk/b=
enefit implications to the Company's clinical development teams; Collabora=
te with biostatisticians, clinicians and clinical operation managers for th=
e appropriate design of Phase I-IV studies; contribute to the investigators=
 brochure, clinical study protocol and report analysis and reporting of dat=
a, and communication of data in regulatory documents and meetings; Drive c=
lin pharm regulatory strategy for projects at all stages -- IND to BLA -- a=
nd defend strategy at regulatory meetings; Help design and conduct transla=
tional PK/PD modelling and simulation to support drug design goals, designs=
 of PK/PD and safety assessment studies, and dosing justifications for firs=
t-in-human clinical studies; Collaborate with toxicologists on the design,=
 monitoring, and reporting of nonclinical safety studies; prepare TK subrep=
orts; comply with good laboratory practice (GLP) regulations for GLP studie=
s. Perform PK analyses for GLP studies per SOPs, record data and analysis r=
esults in GLP-compliant manner, ensure timely and clear communication with =
GLP SD/PI on GLP studies, contribute to GLP study reports; Mentor other ju=
nior PK scientists staff on clin pharm science and strategy.

Essential Requirements
o A doctorate degree in Pharmaceutics/Pharmacy/Engineering/Statistics wi=
th demonstrated expertise in PKPD and clinical pharmacology and strong quan=
titative skills
o Expertise with standard modelling and simulation software (NONMEM, S-P=
lus/R, etc)
o Knowledge of the use of modelling simulation and its role in discovery=
 and development of therapeutics
o Strong publication and conference presentation track-record
For Sr Clinical Pharmacokineticist:
o 5+ years of experience after PhD
For Principal Clinical Pharmacokineticist:
o 8+ years of experience after PhD
Desirable Requirements
o Expertise in other modelling software (e.g. MATLAB, Berkeley-Madonna, =
o Knowledge of bioanalytical expertise, especially of biologics
o Knowledge of biologics discovery and development - especially knowledg=
e of bioanalytical strategy and GLP
o Proven track record of extensive experience in population modeling and=
 simulations using NONMEM
o Familiarity with statistical software package Splus, R or SAS
o Good communication and scientific writing skills, and ability to indep=
endently work in a matrix environment
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full ap=
plication on our website at your earliest convenience - it is the only way =
that our Recruiter and Hiring Manager can know that you feel well qualified=
 for this opportunity. If you know someone who would be a great fit, pleas=
e share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all=
 qualified applicants for employment without discrimination on grounds of d=
isability, sex or sexual orientation, pregnancy or maternity leave status, =
race or national or ethnic origin, age, religion or belief, gender identity=
 or re-assignment, marital or civil partnership status, protected veteran s=
tatus (if applicable) or any other characteristic protected by law. AstraZe=
neca only employs individuals with the right to work in the country/ies whe=
re the role is advertised.

To the extent this electronic communication or any of its attachments conta=
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Received on Mon Apr 24 2017 - 12:35:51 EDT

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