With over 15 years in pharmaceutical R&D, this consultant excels in drug discovery, toxicology, and formulation development, leading teams from target identification to regulatory submissions
Expert in ADME/DMPK studies and pharmacokinetics, they have a proven track record in regulatory compliance, including GLP, GCP, FDA, and EMA standards, offering strategic consulting and scientific advisory roles
As an independent consultant, they have supported biotech firms with strategic R&D planning, regulatory submissions, and provided expert toxicological assessments for EMA scientific advice procedures
Led a team of 20 researchers in ADME/DMPK studies, overseeing non-clinical safety evaluations and representing the company in regulatory meetings with FDA and EMA
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- PhD in Pharmacology and M.Sc. in Biochemistry
- Language Skills
- English (business fluent), German (native), French (conversational)
- Relevant Expertise
- Toxicologist, Drug Discovery, Target Identification, Toxicology, Formulation Development, PK/PD, Regulatory Submissions, Project Management, Scientific Advice
Key-Facts
Extract from previous activities
Global Pharmaceutical Company
interim Head of Toxicology & PK/PD
Led a team of 20 researchers in ADME/DMPK studies
Oversaw non-clinical safety evaluations across multiple drug candidates
Represented company in regulatory meetings with FDA and EMA
Biopharmaceutical Company
Senior Research Scientist
Managed translational research projects from in vitro to in vivo validation
Established new methods for high-throughput screening assays
Published 10+ peer-reviewed papers on pharmacokinetics and toxicology