NONMEM Users Network Archive

Hosted by Cognigen

[NMusers] Novartis: 2 Pharmacometrics positions in Basel, Switzerland

From: Graham, Gordon <gordon.graham_at_novartis.com>
Date: Tue, 24 Jan 2017 15:05:58 +0000

Dear NMusers,

2 Pharmacometrics Scientist positions are now available in Basel, Switzerla=
nd.

Please apply through the links below.


Senior Principal Pharmacometrics Scientist

https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?partnerid=13617&sit=
eid=5260&jobid=2463555&_ga=1.268112330.577526406.1485269654

Job ID

204727BR

Position Title

Senior Principal Pharmacometrics Scientist

Division

Global Drug Development

Business Unit

Global Develop NPH

Country

Switzerland

Work Location

Basel

Company/Legal Entity

Novartis Pharma AG

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Job Description

The Senior Principal Pharmacometrics Scientist leads the planning, executio=
n and delivery of
pharmacometric strategy on assigned projects within (pre/early/full) clinic=
al development.
S/he is responsible for the discussion and implementation of pharmacometric=
 methodologies that
optimally address the research and development objectives on the assigned p=
rojects.
S/he provides pharmacometric support for regulatory submissions, and contri=
butes to drug
development decisions with internal and external partners.

Major Activities:
1. Provide global strategic pharmacometric leadership and support to (pre/e=
arly/full-) clinical
development projects, based on relevant technical and disease area knowledg=
e.
2. Represent the GPT/GCT/CTT (or equivalent) internally and externally as t=
he pharmacometrics
scientist, including in regulatory interactions
3. In collaboration with Development counterparts (Global Brand/Project Med=
ical Directors/
Translational Medicine Experts) and Global Project Teams/GCT/CTTs, provide
pharmacometric support for the quantitative evaluation of competing trial/a=
nalysis strategies
assuring robust support to clinical development planning and execution and =
alignment with
CDPs/TPPs.
4. Develop, write and execute pharmacometric analysis plans, and deliver re=
ports on results.
5. Drive the pharmacometric contributions to regulatory/submission strategy=
 and related
documents (e.g.: Target Product Profile, sPOC document, CDP, Briefing Books=
, Risk
Management Plan and responses to HA questions).
6. Assess pharmacometric requirements for, and ensure integration of pharma=
cometric
information into transition of drug development milestones / decision board=
s.
7. Align the IIS/AQS team (biometrician, data management, database programm=
ing,
programming, medical and scientific writing) on the pharmacometric strategy=
, execution and
delivery of assigned projects.
8. Interact with Health Authorities and external key opinion leaders as the=
 recognized Novartis
pharmacometrics expert at indication (or equivalent) level for all relevant=
 aspects of the
program. Represent AQS at across global regulatory hearings/advisory commit=
tee meetings
and other global regulatory interfaces
9. Provide technical pharmacometrics expertise and identify opportunities f=
or influencing
internal discussions on white papers/regulatory policy.

Minimum requirements

Education and/or professional experience:
Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a =
field with significant modeling-related content (or equivalent Ph.D. / MD)

Languages:
Fluent in English (Oral and written)

Experience / Professional Requirements:
1. 5+ years industry experience
2. 2+ years in applying model based methods in pre-clinical and clinical dr=
ug development. .
3. Contributes to external white-papers/policy shaping best practice in pha=
rmacometrics. Has established track record of developing/establishing pharm=
acometrics excellence. Experience in contributing to scientific improvement=
/change initiatives.
4. Good interpersonal and communication skills (verbal and writing) bridgin=
g scientific and business needs - integrating quantitative sciences, strong=
 disease area knowledge and appropriate market/competitive intelligence
5. Expert knowledge and evidence of hands-on experience in the application =
of pharmacometrics methods to drug development
6. Scientific skills demonstrated in facilitating the (pre/early/full-) cli=
nical development strategy.
7. Clinical, pharmacological and therapeutic knowledge of at least one dise=
ase area
8. Strong skills to facilitate and enable the contribution of quantitative =
teams




Principal Pharmacometrics Scientist

https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?partnerid=13617&sit=
eid=5260&jobid=2463553&_ga=1.227856729.577526406.1485269654

Job ID

204726BR

Position Title

Principal Pharmacometrics Scientist

Division

Global Drug Development

Business Unit

Global Develop NPH

Country

Switzerland

Work Location

Basel

Company/Legal Entity

Novartis Pharma AG

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Job Description

The Principal Pharmacometrics Scientist leads the execution and delivery of=
 pharmacometrics tasks on
assigned projects within (pre/early/full) clinical development.
Together with the AQS franchise leadership, s/he is responsible for the dis=
cussion and implementation
of pharmacometric methodologies that optimally address the research and dev=
elopment objectives
on assigned projects.

1. Provide pharmacometric support for assigned projects, and proactively se=
ek the support and
input from senior AQS colleagues and AQS franchise leadership.
2. In collaboration with Research and Development team members, AQS Franchi=
se Head and
senior AQS associates, negotiate and develop (pre/early/full) clinical tria=
l objectives and
pharmacometric deliverables.
3. In collaboration with partners in (pre-/early/full) clinical development=
 teams (Medical
Scientific Expert/Global Program or Brand Medical Directors/ Translational =
Medicine Experts
and AQS Franchise head), provide pharmacometric support for the quantitativ=
e evaluation of
competing trial/analysis strategies assuring robust support to clinical dev=
elopment planning
and execution and alignment with CDPs/TPPs.
4. In collaboration with AQS franchise leadership write and execute modelin=
g plans, and deliver
reports of results.
5. Contribute to the pharmacometric scientific content of materials for int=
ernal decision
boards/regulatory/submission documents: Briefing Books, decision criteria, =
trial design(s),
responses to trial-specific Health Authority questions.
6. Align the IIS/AQS team (biometrician, data management, database programm=
ing,
programming, medical and scientific writing) on the pharmacometric strategy=
 and execution
on assigned projects.

Minimum requirements

Education and/or professional experience:

Ph.D. in pharmacology, biology, engineering, computational sciences, mathem=
atics, statistics, or a field with significant modeling-related content (or=
 equivalent Ph.D. / MD)

Languages:

Fluent in English (Oral and written)

Experience / Professional Requirements:

1. 2+ years modeling related activity relevant to the role as a pharmacomet=
rician
2. Strong working knowledge / experience with SAS/ R/ Splus MATLAB / NONMEM=
 / Monolix or any other business or research analytic software relevant to =
pharmacometrics.
3. Good interpersonal and communication skills bridging scientific and busi=
ness needs
4. Good scientific leadership skills demonstrated in facilitating the inclu=
sion and execution of pharmacometrics methods.
5. Good team player skills to enable and participate in the contribution of=
 quantitative teams



Gordon Graham
Pharmacometrics
Novartis Pharma AG
Postfach
CH-4002 Basel
SWITZERLAND

Phone +41 61 3246253
Mobile +41 79 3959364
Fax +41 61 3241246
gordon.graham_at_novartis.com<mailto:gordon.graham_at_novartis.com>
www.novartis.com<http://www.novartis.com/>



Received on Tue Jan 24 2017 - 10:05:58 EST

The NONMEM Users Network is maintained by ICON plc. Requests to subscribe to the network should be sent to: nmusers-request@iconplc.com. Once subscribed, you may contribute to the discussion by emailing: nmusers@globomaxnm.com.