Posting for Eli Lilly
Research Advisor - PK/PD
The position will represent Global PK/PD/TS department and provide
PK/PD/TS scientific and technical leadership in the drug discovery,
development and commercialization process. Candidates for the Principle
Research Scientist position will have demonstrated technical capability
and leadership in the context of drug discovery, development, and
commercialization. They are expected to leverage their science to help
drive solutions. Candidates for the Research Advisor will have
demonstrated technical capability in the context of drug discovery,
development, and commercialization. The role requires leadership on
project teams and an ability to integrate data from other disciplines
and understand the high level issues affecting the team. They are
expected to leverage their science to help drive solutions. The majority
of contributions for these positions are at the portfolio level.
KEY OBJECTIVES/DELIVERABLES:
1. Responsible for developing PK/PD sections of program and product
team plans
2. Lead preparation of Phase I, II, and III study protocols
3. Provide scientific interpretation of conventional and population
PK/PD analyses and preparation of study reports
4. Responsible for preparation of INDs, IBs, CTDs and other
regulatory documents for development and registration of new drugs
MINIMUM REQUIREMENTS:
* Ph.D in scientific field
* 5-10 years experience in pharmaceutical sciences or commensurate
experience in Pharmaceutical Sciences, Pharmacology, or similar
scientific discipline
* Expertise in PK/PD and population modeling and simulation
* Knowledge and experience in the area of
Pharmacokinetics/Pharmacodynamics area and its role of in drug research
and development
* Working knowledge of software such as NONMEM, SAS, S-Plus and
WINNONLIN is required .
ADDITIONAL SKILLS/PREFERENCES:
* Excellent communication, presentation, and written skills
* Able to effectively work with senior management while balancing
quality and speed in complex situations
* Proficiency with the theory and application of PK/PD,
compartmental and noncompartmental analyses and fundamentals of
pharmacostatistical modeling
* On the job training or industrial experience with submissions to
regulatory agencies
* Knowledge of the role of PK/PD in drug development and FDA/ICH
requirements for drug registration
* Familiarity with experimental study design
OTHER CONSIDERATIONS:
* Some travel required.
Please apply directly:
https://careers.peopleclick.com/careerscp/client_lilly/external/gateway.
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