Kaztronix
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Director Clinical Pharmacokineticist
Job Description
Job Summary
The Director Clinical Pharmacokineticist (PSR) role is responsible for provide strategic and scientific expertise on clinical pharmacology development plan, lead the development of PK and PK/PD analysis plan, performing PK and PK/PD analysis and reporting for biologics and small molecules in the clinical pharmacokinetics group.
Summary of the Essential Functions of the Job
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
The Director Clinical Pharmacokineticist (PSR) role is responsible for provide strategic and scientific expertise on clinical pharmacology development plan, lead the development of PK and PK/PD analysis plan, performing PK and PK/PD analysis and reporting for biologics and small molecules in the clinical pharmacokinetics group.
Summary of the Essential Functions of the Job
- Represent Clinical PK & Clinical Pharmacology in project teams.
- Develop or provide consultation on clinical pharmacology plan to support clinical trial development.
- Advise clinical teams on PK and PK/PD study design.
- Develop or co-develop PK and PK/PD analysis plan, perform PK and PK/PD analyses (interim and/or final), interpret and report data to clinical teams and management to support dose recommendations for clinical studies in different phrases.
- Generate or supervise the generation of PK and ADA (anti-drug antibody) TFLs
- Write clinical PK and PK/PD reports
- Provide significant contributions to and review relevant clinical pharmacology sections of IBs and CSRs
- Provide significant contributions to and review relevant PK and clinical pharmacology sections of submission documents (Briefing Package, CTD Module 2.7.1, Module 2.7.2, Module 5.3.5.3, etc) to regulatory agencies
- Creation, modification, and review of data specifications for clinical PK and ADA analysis;
- Work with clinician, biostatistician, and data manager to provide deliverables on time.
- Present work at internal and external scientific meetings and publish manuscripts in peer-reviewed journals.
- Ph.D. Or (M.Sc. Plus 3 years) in Pharmacokinetics, Pharmacometrics, Pharmacology, or related fields.
- 10-15 years of related industry and/or FDA experience.
- Extensive experience in clinical PK study design, analysis and reporting.
- Expert experience with software packages, such as but not limited to: WinNonlin.
- Extensive experience with writing reports for regulatory submissions.
- Excellent written and verbal communication skills.
- Appropriate publication record is desirable.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
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