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 development
of new drugs within Vertex Pharmaceuticals and our goal is to fully implement
Model based principles to support drug development program in terms of
translational modeling, clinical study design, evaluation and decision making.
We are now seeking an experienced Pharmacometrician (corresponding to Director
level) to our Modeling & Simulations Department to help us achieve this
vision. The successful candidate will be responsible for developing and
executing M&S strategies in several cross functional drug development project
teams and work in close collaboration with colleagues in Clinical Pharmacology,
Biostatistics, Clinical Biomarkers, Clinical Development and other colleagues
within the clinical and preclinical organization. The successful candidate will
play a key role in building the Pharmacometrics capability within Vertex by
providing technical and strategic support to other modelers within the
Department, organize training as needed and contribute to building a
sustainable Modeling infrastructure.
Key responsibilities:
* As M&S lead in one or more cross functional drug development teams,
provide modeling and quantitative expertise, develop Modeling & Simulation
plans 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 trial
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 training
sessions in relevant areas as needed.
* Establish strong relationships with colleagues within Biostatistics,
Clinical Pharmacology, Clinical biomarkers, DMPK and other quantitative
disciplines 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
degenerative diseases.
Required Qualifications
* PhD (with an emphasis on pharmacometric methodologies) in:
pharmacokinetics, pharmacodynamics, clinical pharmacology, statistics,
bioengineering, or other quantitative discipline.
* 10+ yrs hands-on experience in the application of Pharmacometric
methodologies within the context of drug development.
* Expert knowledge in population-based PK, PKPD, exposure/dose-response
analyses, clinical trial simulation, Bayesian approaches, Meta analyses,
Adaptive design etc
* A solid understanding of pharmacokinetic and PKPD principles. Excellent
programming skills ( NonMem, R, S Plus, SAS etc.)
* Demonstrated strong experience from interactions with regulatory
authorities and good insight into regulatory guidelines and expectations with
respect to the use of model based methodologies in e.g. NDA filings, EoPh2
meetings 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 reach a
common goal. Demonstrated strong experience from interactions with regulatory
authorities and good insight into regulatory guidelines and expectations with
respect to the use of model based methodologies in e.g. NDA filings, EoPh2
meetings etc.
Desirable qualifications
* Experience from the application of System pharmacology in a drug
development context.
* ModelingExperience from disease areas like Pulmonary diseases, Oncology
and Neurodegeneratve diseases
Vertex is a global biotechnology company that aims to discover, develop and
commercialize innovative medicines so people with serious diseases can lead
better lives. In addition to our clinical development programs focused on
cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed
at other serious and life-threatening diseases.
If you have questions about the position, please contact
Ulf Bredberg at [email protected]<mailto:[email protected]>
To apply for this position please follow the link below.
http://careers.vrtx.com/jobs/descriptions/modeling-simulation-director-level-boston-massachusetts-job-1-4701831
This email message and any attachments are confidential and intended for use by
the addressee(s) only. If you are not the intended recipient, please notify me
immediately by replying to this message, and destroy all copies of this message
and any attachments. Thank you.