MAJOR RESPONSIBILITIES
* Create an optimal PK/PD strategy (including timelines and budget) for
biologics in early and full development in liaison with other line functions
and Management.
* Interpret study results in conjunction with laboratory functions and
present study results and recommendations to project teams and Management Team.
* Represent department on cross-functional Project Teams.
* Create PK, PK/PD and Modeling & Simulation component of study
protocols, 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 Diligence
activities as required.
KEY QUALIFICATIONS & CAPABILITIES
* Expertise in utilizing PK/PD to efficiently advance Biologics to milestone
points in the drug development process
* Ability to create and implement novel strategies to address PK/PD questions
* Deep knowledge of PK/PD; cutting-edge approaches and technologies to
address 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
disciplines 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 / business
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 Team
timelines and budget
* Acceptance of PK/PD plans by Company decision making boards and
Regulatory Agencies
* PK/PD aspects of drug development plan enacted according to timelines
and budget
* Resolution of internal issues or issues with regulatory agencies;
* Satisfaction of supervisor with quality and timing of contributions.
EDUCATION / EXPERIENCE
Minimum education: PhD in natural/biological sciences (e.g.
PK/PD), PharmD or equivalent with a focus on biologics or industrial experience
with the development of biologics.
Languages: English written & spoken
(required)
Ideal experience: 5-10 +years experience in
representing PK/PD on cross-functional project teams responsible for the
development of biologics. Advanced knowledge of PK/PD of biologics and
relevant laboratory tools and procedures. Proficient in the interpretation of
PK/PD modeling 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
[email protected]
http://www.greylock-recruiting.com/
[cid:[email http://www.linkedin.com/in/greylock
Please Note:
The information in this e-mail message is legally privileged and
confidential information intended only for the use of the addressee(s)
named above. If you, the reader of this message, are not the intended
recipient, you are hereby notified that you should not further
disseminate, distribute, or forward this e-mail message. If you have
received this e-mail in error, please notify the sender as soon as
possible. In addition, please delete the erroneously received message
from any device/media where the message is stored.
<<inline: image001.gif>>