| About our client |
| Our client is a specialty generic pharmaceutical company engaged in the formulation and commercialization of both controlled release ("CR") and immediate release ("IR") products utilizing its proprietary drug delivery technologies. Using these technologies on selected generic prescription pharmaceuticals, they aim to reproduce the release characteristics of these drugs so as to manufacture and market versions for brand product substitution. Our client intends to develop and use their drug delivery technologies to commercialize a portfolio of generic pharmaceutical products. In the near future, they also plan to apply the company’s drug delivery technologies to the development of proprietary branded drugs. |
| Position |
Location |
| Director/Manager of Pharmaceutics |
Florida |
| Salary |
Reports to |
| Highly competitive package, commensurate with experience |
Senior Director, Project and Site Management |
| Responsibilities |
1) Conduct advanced research towards the development of generic pharmaceutical products and process pharmaceutical methodologies
2) Work with teams of pharmaceutical scientists, technicians and support staff engaged in complex research assignments
3) Perform various tasks such as plan, coordinate, audit of internal/external clinical, analytical and statistical research programs implemented for the evaluation of bioavailability and bioequivalence of the drug products
4) Perform the pharmacokinetic and statistical analyses and interpret the pharmacokinetic results
5) Create and administer study plans
6) Manage pre/post audits
7) Procure study bids
8) Prepare study protocols and related duties (as assigned)
9) Provide clinical timelines
10) Ensure compliance with federal regulations
11) Perform literature search, PK/PD modeling and simulations
12) Evaluate all events during the clinical study phase
13) Interact with government regulatory agencies to design, organize and manage full cycle of clinical studies
14) Develop and use generic computer modeling and/or simulation tools to support generic drug development projects
15) Perform PK/PD modeling and explore new methods to improve the drug development process while working on project teams and sharing the results of the analysis
16) Guide the decisions of clinical studies, specifically performance analysis of pharmacokinetic results |
| Requirements |
1) Ph. D. in Pharmacokinetic/Pharmacology/Toxicology or a related discipline
2) Minimum 4 – 6 years of pharmaceutical experience specifically in pre-clinical or clinical pharmacokinetic/pharmacodynamic studies
3) Sound experience of dosage
4) Experience in a generic pharmaceutical industry preferred
5) Experience in PK/PD modeling and/or computer simulation
6) Self-directed and very conversant with pharmaceutical methodologies
7) Solid background and understanding of pharmacokinetic
8) Familiarity with modeling software (e.g., WinNonlin)
9) Proficiency in computers
10) Ability to work well in a team-oriented environment
11) Strong communication skills |
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