Senior Pharmacometrician at Vertex- (Director level)
Functional Area: Modeling&Simulation, Clinical Development
Location: Boston, Massachusetts
Position Responsibilities:
Modeling & Simulations plays an increasingly important role in the developm=
ent of new drugs within Vertex Pharmaceuticals and our goal is to fully imp=
lement Model based principles to support drug development program in terms =
of translational modeling, clinical study design, evaluation and decision m=
aking.
We are now seeking an experienced Pharmacometrician (corresponding to Direc=
tor level) to our Modeling & Simulations Department to help us achieve thi=
s vision. The successful candidate will be responsible for developing and e=
xecuting M&S strategies in several cross functional drug development projec=
t teams and work in close collaboration with colleagues in Clinical Pharmac=
ology, Biostatistics, Clinical Biomarkers, Clinical Development and other c=
olleagues within the clinical and preclinical organization. The successful =
candidate will play a key role in building the Pharmacometrics capability w=
ithin Vertex by providing technical and strategic support to other modelers=
within the Department, organize training as needed and contribute to build=
ing a sustainable Modeling infrastructure.
Key responsibilities:
* As M&S lead in one or more cross functional drug development teams, p=
rovide modeling and quantitative expertise, develop Modeling & Simulation p=
lans that are integrated with the clinical development plans, contribute to=
optimal trial design, support dose and patient selection,
* Perform population PK and dose/exposure response analyses,clinical tr=
ial simulations, probability of success estimations, contribute to optimal =
dose selection, interact with regulatory authorities and contribute to IND =
and NDA filings.
* Strongly contribute to the implementation of pharmacometric/modeling =
strategies and methodologies across projects and disease areas.
* Provide technical and tactical guidance to other Modeling colleagues =
within the M&S department on a day-to-day basis and initiate internal train=
ing sessions in relevant areas as needed.
* Establish strong relationships with colleagues within Biostatistics, =
Clinical Pharmacology, Clinical biomarkers, DMPK and other quantitative dis=
ciplines within Vertex.
* Establish and build strong connections with M&S colleagues within top=
Academic institutions.
* Take a leading role in the evaluation of new Pharmacometric tools and=
contribute to a strong and sustainable computational infrastructure for de=
generative diseases.
Required Qualifications
* PhD (with an emphasis on pharmacometric methodologies) in: pharmacoki=
netics, pharmacodynamics, clinical pharmacology, statistics, bioengineering=
, or other quantitative discipline.
* 10+ yrs hands-on experience in the application of Pharmacometric meth=
odologies within the context of drug development.
* Expert knowledge in population-based PK, PKPD, exposure/dose-response=
analyses, clinical trial simulation, Bayesian approaches, Meta analyses, A=
daptive design etc
* A solid understanding of pharmacokinetic and PKPD principles. Excelle=
nt programming skills ( NonMem, R, S Plus, SAS etc.)
* Demonstrated strong experience from interactions with regulatory auth=
orities and good insight into regulatory guidelines and expectations with r=
espect to the use of model based methodologies in e.g. NDA filings, EoPh2 m=
eetings etc.
* Demonstrated strong leadership and influencing skills. Excellent oral=
and written communication skills. A demonstrated ability and aspiration to=
collaborate with colleagues within and outside your own discipline to reac=
h a common goal. Demonstrated strong experience from interactions with regu=
latory authorities and good insight into regulatory guidelines and expectat=
ions with respect to the use of model based methodologies in e.g. NDA filin=
gs, EoPh2 meetings etc.
Desirable qualifications
* Experience from the application of System pharmacology in a drug deve=
lopment context.
* ModelingExperience from disease areas like Pulmonary diseases, Oncolo=
gy and Neurodegeneratve diseases
Vertex is a global biotechnology company that aims to discover, develop and=
commercialize innovative medicines so people with serious diseases can lea=
d better lives. In addition to our clinical development programs focused on=
cystic fibrosis, Vertex has more than a dozen ongoing research programs ai=
med at other serious and life-threatening diseases.
If you have questions about the position, please contact
Ulf Bredberg at ulf_bredberg
To apply for this position please follow the link below.
http://careers.vrtx.com/jobs/descriptions/modeling-simulation-director-leve=
l-boston-massachusetts-job-1-4701831
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Received on Mon Sep 15 2014 - 10:46:39 EDT
