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The following message was posted to: PharmPK
New Jersey - Modeling and simulation position in the department of
Clinical Pharmacology & Drug Dynamics (CPDD)
Duties and Responsibilities
1. Develop and execute appropriate pharmacokinetic (PK) and
pharmacodynamic (PD) models, including population PK/PD analyses
2. Provide modeling and simulation (M&S) support to development projects
3. Conduct simulations to support clinical trial design at various
phases of drug development
4. Provide input into protocol and CRF design for collection of PK/PD
data
5. Create M&S datasets and/or provide PK and PD dataset specifications
to statistical programmers for creation of M&S datasets
6. Prepare M&S analysis plans and reports. Provide M&S input into
INDs, NDAs, etc.
7. Support and defend M&S analyses and interpretations at Regulatory
Authorities
8. Interact with outside collaborators that provide M&S expertise
9. Participate in in-licensing evaluations and due diligence
activities, as appropriate
10. Assist in the assessment and development of new M&S software
11. Mentor scientists within CPDD
Education: PhD in pharmacokinetics/pharmacodynamics or related
discipline, MD or PharmD
Experience: Minimum of 2 years experience in the conduct of M&S
projects, preferably supporting clinical trials
Knowledge, Skills, and Abilities
1. Knowledge and proficiency with the theory and application of PK/PD,
compartmental, and noncompartmental analyses and fundamentals of
pharmacostatistical modeling
2. Hands-on experience in M&S software including NONMEM, WinNonlin,
Trial simulator (TS), S-Plus, and SAS
3. Knowledge of the role of PK/PD analyses in drug development and FDA/
ICH requirements for drug registration
4. Excellent verbal, written, and presentation skills
5. Multidisciplinary collaborations
submitted by cindy.at.snellingnj.com
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