[NMusers] Open Position at Daiichi Sankyo - Director of Modeling and Simulation

From: Kang, Dongwoo <dkang_at_dsi.com>
Date: Tue, 14 Aug 2018 17:01:21 +0000

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 =
countries, Daiichi Sankyo and its 15,000 employees around the world draw up=
on a rich legacy of innovation and a robust pipeline of promising new medic=
ines to help people. In addition to a strong portfolio of medicines for hyp=
ertension and thrombotic disorders, under the Group's 2025 Vision to become=
 a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daii=
chi Sankyo research and development is primarily focused on bringing forth =
novel therapies in oncology, including immuno-oncology, with additional foc=
us on new horizon areas, such as pain management, neurodegenerative disease=
s, heart and kidney diseases, and other rare diseases.

Job Description:

The purpose of this position is to conduct population PK/PD analysis for po=
oled Phase 1 studies, perform trial simulation for Phase 2/3 studies, and w=
rite M&S reports. This position demonstrates significant knowledge of poole=
d Phase 1 studies, PK/PD and biomarker data, PK/PD analysis-ready data file=
 derivation, complex disease modalities, regulatory guidelines pertaining t=
o M&S, and programming and analytical software. This position works indepen=
dently on complex studies/models and interacts effectively with project tea=
m members, CRO, and regulatory agencies.

Responsibilities:

Analyzes and presents pooled Phase 1 studies while delivering best practice=
 elements and driving global standards

Conducts trial simulations for Phase 2/3 studies; characterizes the time co=
urse of disease progression for complex disease modalities

Writes M & S documents (e.g. M&S report, analysis plan, dataset specificati=
on)

Works independently on complex studies/models while interacting effectively=
 with internal colleagues, external CROs, as well as regulatory agencies

Qualifications:

* PhD with a minimum of 6 years of industry experience, or MS with 8=
 years of industry experience or equivalent

* Proficiency in quantitative analyses (including population PK, PK/=
PD, exposure-response, and drug-disease modeling) and clinical trial simula=
tions

* Prior experience in applying modeling and simulation to clinical d=
evelopment of oncology products, particularly ADCs

* Familiarity with following systems: NONMEM, R, PsN, Xpose, WinNONL=
IN (Phoenix)

* Solid proficiencies in written and verbal communication, interpers=
onal skills, problem scoping and planning, and the ability to participate i=
n interdisciplinary teams.



Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. =
All qualified applicants will receive consideration for employment without =
regard to sex, gender identity, sexual orientation, race, color, religion, =
national origin, disability, protected veteran status, age, or any other ch=
aracteristic protected by law.



Contact:

Rheischober_at_dsi.com<mailto:Rheischober_at_dsi.com>



Daiichi Sankyo career site:

https://www.linkedin.com/jobs/view/799999419/



Received on Tue Aug 14 2018 - 13:01:21 EDT

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