The role: Director (Sr. Pharmacometrician) / Associate Director
(Pharmacometrician) Multiple Openings
*Description*
*This position could be a Career Level E or F depending upon the level of
experience of the selected candidate.*
AstraZeneca is one of the world's leading pharmaceutical companies, with
strong positions in many therapeutic areas of the global pharmaceutical
market. AstraZeneca's Research & Development is based in a number of
centres of excellence with state of the art facilities in Sweden, United
Kingdom and North America. AstraZeneca has a world-class record of
innovative, important prescription medicines for the treatment of
gastrointestinal, cardiovascular, and respiratory diseases, cancer,
diseases of the central nervous system, as well as treatment of pain.
In our efforts to bring better medicines to patients faster, AstraZeneca
recognizes the critical role modeling and simulation play in nearly all
aspects of drug discovery and development. We also recognize that our
projects have benefited greatly from the consistent, integrated application
of cutting-edge modeling and simulation approaches. To realize this
ambition, we are making significant investments in people and in the
underlying science and technology. Our vision is that all aspects of every
project, from target validation to clinical trial design and
interpretation, will utilize modeling and simulation in synergy, thereby
making the results of our modeling and simulation efforts greater than
simply the sum of the individual parts.
The role
This is a scientific role within our Quantitative Clinical Pharmacology
group which is involved in candidate drug (CD) selection and in all
clinical phases of the product development including registration and
commercialization. We are looking for an individual to fill the role of a
Director (Sr. Pharmacometrician) / Associate Director (Pharmacometrician)
in the US.
In the implementation of Model Based Drug Development (MBDD), the Sr.
Pharmacometrician (Sr PM) will work closely together with other modeling
skills (such as preclinical PKPD scientists, statistical modelers etc ) to
develop MBDD plans for disease area related as well as compound related
modeling. The Sr. PM will develop pharmaco-statistical models including
disease models, exposure response models, biomarker - efficacy models etc.
The Sr. PM will work as a partner in multi-disciplinary development teams
by providing MBDD expertise. Effective collaborations with physicians, DMPK
PK/PD scientists, statisticians, clinical pharmacologists and regulatory
affairs experts are of key importance.
The Sr. Pharmacometrician will, together with statisticians, have the
overall accountability for the MBDD plan. We will also look to this
individual to collaborate externally by publishing their work, building
relationships with academic institutions and building their expertise by
networking with individuals in the pharmacometric field. Individuals in the
senior role will also be called upon to coach less senior staff in their
modeling work.
*Requirements*
*Minimum experience:*
For the Pharmacometrician role, candidates will have a doctorate degree
(preferred) but a Master's degree and other relevant academic training is
acceptable. Candidates should have demonstrated expertise in
pharmacometrics and strong quantitative skills (e.g. experience in
mechanistic modeling/systems pharmacology, quantitative translational
scaling, literature meta-analyses, population modeling). The PM's
experience may have been gained in a variety disciplines including
pharmacology, pharmaceutical sciences, biostatistics, medicine,
mathematics, physiology, or engineering.
For the Sr. Pharmacometrician role, a doctorate degree with demonstrated
expertise in pharmacometrics and strong quantitative skills (e.g.
experience in mechanistic modeling/systems pharmacology, quantitative
translational scaling, literature meta-analyses, population modeling) is
required. The Sr. PM's experience (>10 years) may have been gained in a
variety disciplines including pharmacology, pharmaceutical sciences,
biostatistics, medicine, mathematics, physiology, or engineering. A minimum
of 5 years pharmaceutical industry experience, specifically contributing to
pharmacometrics aspects of clinical drug development, is essential. As is
an in-depth knowledge of advanced PK and PK/PD, a proficiency with
pharmacometric/statistical software tools such as NONMEM, SAS, S-Plus, R,
Matlab, Berkeley Madonna, a knowledge of FDA/ICH requirements for drug
registration, knowledge of Bayesian methods and Monte-Carlo simulation, PK
and PD drug interactions, in vivo/in vitro models, biopharmaceutics and the
ability to understand, and implement all aspects of pharmacometrics needs
across a variety of disease areas.
*Location*
MA, Waltham
External website: http://bit.ly/143B4Nn