Maxim Soloviev
Executive Director, Toxicology at Incyte
- Role
- Executive Director, Toxicology at Incyte
- Location
- Wilmington, DE, US
- LinkedIn followers
- 500 followers
Experience
Executive Director, Toxicology
Feb 2024 — Present · Wilmington, DE, US
Pre-clinical development: Design, placement, management, and reporting of toxicology and safety pharmacology studies (internally and at contract research organizations)responsible for toxicology and safety pharmacology studies * In-house expertise for safety pharmacology studies needed to support preclinical and clinical development, author regulatory submissions related to same;* Assessment of cardiovascular data obtained in clinical trials* Interpretation and reporting study data to internal and external working groups including the clinical development team* Preparation of the reports and documents for nomination and regulatory submissions* Preparation of toxicology and safety pharmacology sections for IND and NDA submissions* Toxicological support for clinical studies
Education
Pavlov Medical University of St. Petersburg
PhD, Surgery, Cardiology, and Metabolic Diseases
1989 — 1992
Pavlov Medical University of St. Petersburg
MD, Medicine
1981 — 1987
Skills
- Toxicology
- CRO Management
- Adme
- Ind
- Clinical Study Design
- U.s. Food and Drug Administration (Fda)
- Biomarkers
- CRO
- Cardiology
- Translational Medicine
- Good Laboratory Practice (Glp)
- Drug Discovery
- Pharmacokinetics
- Life Sciences
- Regulatory Affairs
- Lifesciences
- R&D
- Physiology
- Oncology
- Glp
- Translational Research
- Pharmacology
- Drug Development
- Nda
- Bioanalysis
- Clinical Trials
- Dmpk
- Biotechnology
- Research and Development (R&D)
- Safety Pharmacology
- Regulatory Submissions
- In Vivo
- Immunology
- Assay Development
- Pharmaceutical Industry
- Sop
- Fda
- Animal Models
- In Vitro
- Drug Metabolism
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