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Exciting PK/PD Opportunity

From: T.J. Elder <telder>
Date: Tue, 24 Mar 2009 12:48:31 -0700

MAJOR RESPONSIBILITIES
* Create an optimal PK/PD strategy (including timelines and budget)=
 for biologics in early and full development in liaison with other line fun=
ctions and Management.
* Interpret study results in conjunction with laboratory functions =
and present study results and recommendations to project teams and Manageme=
nt Team.
* Represent department on cross-functional Project Teams.
* Create PK, PK/PD and Modeling & Simulation component of study pro=
tocols, reports, project and regulatory summaries and development plans.
* Interact with Health Authorities as necessary.
* Leads or participates in Early Development sub-teams and/or Line =
Function specific teams.
* Evaluates in-licensing opportunities and carries out Due Diligenc=
e activities as required.

KEY QUALIFICATIONS & CAPABILITIES

 * Expertise in utilizing PK/PD to efficiently advance Biologics to miles=
tone points in the drug development process
 * Ability to create and implement novel strategies to address PK/PD ques=
tions
 * Deep knowledge of PK/PD; cutting-edge approaches and technologies to a=
ddress PK/PD questions; ability to rapidly identify and assimilate relevant=
 information from competitor's programs; deep understanding of existing and=
 proposed regulatory guidance's
 * Strong understanding of how PK/PD inter-relates to other technical dis=
ciplines and the contribution of these disciplines to the drug development =
process.
* Ability to work independently with minimal day-to-day direction, =
as well as work in a global, multicultural collaborative team environment
* Ability to create cross-functional teams driven by project / busi=
ness needs; ability to influence teams without direct authority
* Able to manage multiple competing priorities simultaneously

JOB DIMENSIONS

Number of associates: 0


KEY PERFORMANCE INDICATORS / MEASURES OF SUCCESS

* Robust plans to address PK/PD of the drug according to Project Te=
am timelines and budget
* Acceptance of PK/PD plans by Company decision making boards and R=
egulatory Agencies
* PK/PD aspects of drug development plan enacted according to timel=
ines and budget
* Resolution of internal issues or issues with regulatory agencies;
* Satisfaction of supervisor with quality and timing of contributio=
ns.

EDUCATION / EXPERIENCE

Minimum education: PhD in natural/biological sciences (e.g=
. PK/PD), PharmD or equivalent with a focus on biologics or industrial expe=
rience with the development of biologics.

Languages: English written & spoken (r=
equired)


Ideal experience: 5-10 +years experience in repres=
enting PK/PD on cross-functional project teams responsible for the developm=
ent of biologics. Advanced knowledge of PK/PD of biologics and relevant la=
boratory tools and procedures. Proficient in the interpretation of PK/PD m=
odeling and simulations. Excellent knowledge of regulatory guidance's and =
best practices for the development of biologics.




T.J. Elder
Principal Search Consultant
Preclinical and Clinical Development
Greylock Recruiting, LLC
Tel: 413-458-1000
Fax: 617-716-4444
Cel: 617-680-1952
telder

http://www.greylock-recruiting.com<http://www.greylock-recruiting.com/>

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Received on Tue Mar 24 2009 - 15:48:31 EDT

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