| Pharmacokineticist
(FullTime) |
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Preparation of NDA Essential Documents dealing with clinical pharmacokinetic/pharmacodynamic information
Otherwise support Macugen franchise in AMD indication and new indications
Summary
- Ability to write phase 1 and phase 2 clinical protocols without extensive guidance
- Ability to draft with assistance a phase 1 and phase 2 project plan
Evaluation and quality check of data tables/listings, statistical evaluations
- Perform model-independent, model-dependent pharmacokinetic/pharmacodynamic data analyses using standard software packages (population PK or PD analyses skills desirable)
- Produce a data archival package for pharmacokinetic/pharmacodynamic data analyses and reports
- QC of prepared documents for regulatory submission or internal use.
Qualifications
- Familiarity with regulatory guidance dealing with health authority documentation and submissions.
- Experience in clinical pharmacokinetic/pharmacodynamic data analyses especially as it relates to NDA submissions.
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Experience with preparation of clinical protocols, study reports and preclinical protocols and study reports; NDA summary documents and monographs.
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Highly desirable is graduate degree in clinical pharmacology, pharmacokinetics or pharmaceutics (PhD or PharmD)
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