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发帖数: 3030 | 1 Contact the recruiter directly please
Principal Research Scientist-PK/PD- Indiana -
The Principal Research Scientist functions as a project leader in a
multidisciplinary team environment with primary responsibility for the early
preclinical development of antibodies and protein molecules.
KEY OBJECTIVES/DELIVERABLES:
- Integrate pharmacokinetics and PK/PD with discovery biology to define
structure activity relationships to guide protein engineering strategies and
to help optimize development of protein therapeutics. Interact across
groups, including other departments, regulatory agencies, and functional
groups within drug disposition.
- Responsible for the design, conduct, interpretation and reporting of study
results.
- Design/execution of preclinical PK/PD studies
- Develop and apply PK/PD modeling strategies
- Write preclinical and clinical study reports
- Interface with biology, toxicology and clinical research
- Bioanalytical method development/validation
Visa Candidates Considered
The Candidate
5+ to 7 years of experience
Minimum Education - Doctoral
MINIMUM REQUIREMENTS:
- Ph.D. in Pharmacokinetics/Pharmacodynamics or a related field in
Pharmaceutical Sciences, with experience in PK/PD modeling.
- 5 years of industry (Pharma/Biotech) experience with PK/PD modeling of
monoclonal antibodies, peptides/proteins or fusion proteins.
- Strong working knowledge of software such as WinNonlin, NONMEM and S-Plus.
- Experience in the design and execution of PK/PD studies and development of
mathematical PK/PD models.
ADDITIONAL PREFERENCES:
- Strong working knowledge of immunoassay methodology is desirable.
AND
Research Advisor - PK/PD- Indianapolis
KEY OBJECTIVES/DELIVERABLES:
Responsible for developing PK/PD sections of program and product team plans
Lead preparation of Phase I, II, and III study protocols
Provide scientific interpretation of conventional and population PK/PD
analyses and preparation of study reports
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
5-10-15 years of 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
Previous regulatory experience (CDER and CDRH) with a minimum of 5 years
experience in regulatory affairs especially with In Vitro Diagnostics (IVDs)
Applicable device/IVD development experience
Applicable drug development experience
Knowledge of FDA drug and diagnostic regulations, procedures and practices
across divisions (Regulations, Guidance documents, PDUFA, FDAMA, MDUFA, etc.)
Knowledge of drug and diagnostic development process strategies/plans
Awareness of evolving regulatory reform initiatives and pending changes (
Federal Register, RIGO, etc.)
OTHER CONSIDERATIONS:
Some travel required.
Visa Candidates Considered
The Candidate
10+ to 15 years of experience
Management Experience Required - No
Minimum Education - Doctoral
Willingness to Travel - Occasionally
Regards, ciao, Namaste, Peace
Joe
Joseph Anthony Vaccariello
j********[email protected]
http://www.linkedin.com/pub/3/945/77
A New Beginning-Genesis 2
http://www.anewbeginning-genesis2.com
860 889 4141, until 9 PM Eastern, 7 days a week |
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