Sr. Director Modeling & Simulation
Job Description
We are currently seeking a Sr Director, Modeling and Simulation for our Edison,
New Jersey location. This position is responsible for ensuring state-of-the-art
modeling and simulation is used during preclinical and clinical development to
support product development and decision making.
Responsibilities: In this role, you will develop and implement modeling and
simulation plans for all compounds in development that contribute to dose
selection, issue resolution and decision making in conjunction with Translation
Medicine, Clinical Pharmacology and Clinical Development. You will also direct
internal and external resources to perform key model based analyses; develop
innovative study designs for translational medicine and clinical pharmacology
studies; work with Bioinformatics on strategies to support translational
medicine and clinical pharmacology activities; assist with coordination of key
opinion leaders, consultants and other therapeutic area specialists in the drug
development process; support model based predictions of human pharmacokinetics
and pharmacodynamics based on preclinical data; and manage and coach direct
line reports.
Education/Experience Qualified candidates must have a Ph.D. in Pharmaceutical
science or equivalent. Minimum of 8 years of clinical pharmacology and
pharmacokinetics experience, including implementation of state of art modeling
and simulation to support compound development. In-depth knowledge of current
regulatory requirements (FDA, GCP and ICH). Ability to work independently and
to effectively prioritize, proactively identify and resolve problems and work
in a team environment. Must possess excellent organizational, communication and
interpersonal skills, as well as effective collaboration and negotiation
techniques. Highly proficient in standard computer software (Word, Excel and
Power Point) and helpful to have proficiency in specialized software for
pharmacokinetic data analysis. Demonstrated experience in population
pharmacokinetic-pharmacodynamic modeling required. Experience in clinical
trials simulation desirable.
Company Description
Daiichi Sankyo Pharma Development is responsible for the regional delivery of
global clinical trials. Our highly skilled staff develop and manage clinical
trials conducted in North, South and Central America and submit product
applications to the local health authorities. Within Daiichi Sankyo's R&D
global matrix organizational structure, our employees work in a highly
collaborative environment where novel ideas are exchanged. In our pursuit to
identify innovative treatments, we work tirelessly to identify opportunities to
bring treatments to the patients who need them.
Please Contact Scott Sugarman - Human Resources at 732-590-5036 or
[email protected]
Scott Sugarman | Recruiter, Human Resources
____________________________________________
Daiichi Sankyo Pharma Development
399 Thornall St.| Edison, NJ 08837
Tel: 732 590-5036| Fax: 732 906-8031
Email: [email protected]<mailto:[email protected]>
Career Site: http://www.dsicareers.com/
Website: http://www.dsi.com/