Paul Statkevich
Pharmaceutical Professional: Clinical Pharmacology | Pharmacometrics | PK-PD | Drug Development | DMPK
- Role
- Senior Director, Clinical Pharmacology & Pharmacometrics at Bristol Myers Squibb
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Paul Statkevich
Pharmaceutical professional with experience across all phases of drug development in Clinical Pharmacology & Pharmacometrics, preclinical & clinical PK/PD, and DMPK. Project team and governance committee representative developing and implementing PK/PD, clinical pharmacology, and DMPK drug development registration strategies across therapeutic areas. Prepared Clinical Pharmacology, biopharmaceutics and PK/PD components of submissions and labels to successfully register temozolomide PO & IV [Temodar], ezetimibe [Zetia], ezetimibe/simvastatin [Vytorin] combination, nivolumab [Opdivo] and nivolumab/ipilimumab combination. Leader providing performance management and scientific supervision to recruit, motivate, mentor and coach colleagues. Specialties:Clinical Pharmacology, PK/PD, Pharmacometrics, ADME, drug development, biopharmaceutics, regulatory submissions / interactions, Project Representative, oncology and immuno-oncology development, project management
Experience
Senior Director, Clinical Pharmacology & Pharmacometrics
Apr 2020 — Present · Lawrenceville, NJ, US
Education
The University of Connecticut, Pharmacy, BSc
Bachelor of Science (BSc), Pharmacy
The University of Connecticut, Pharmacy, Ph.D.
Ph.D., Pharmaceutical Sciences, Pharmacokinetics
Skills
- Pharmaceutics
- Drug Discovery
- Clinical Trials
- Clinical Development
- Biomarkers
- CRO
- Glp
- Clinical Research
- Clinical Pharmacology
- Good Laboratory Practice (Glp)
- Ind
- Drug Development
- Gcp
- Translational Medicine
- Pk/Pd
- Therapeutic Areas
- Pharmacology
- Ctms
- Pharmaceutical Research
- Pharmacometrics
- Infectious Diseases
- Drug Metabolism
- Pharmacovigilance
- Medical Writing
- Medical Affairs
- Regulatory Submissions
- Pharmaceutical Industry
- Sop
- Standard Operating Procedure (Sop)
- Oncology
- Adme
- Dmpk
- Biotechnology
- Pharmacokinetics
- Pharmacodynamics
- Good Clinical Practice (Gcp)
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