Job summary
This senior-level position involves leading pharmacokinetic activities within clinical pharmacology and drug metabolism teams. The role requires close collaboration with international clients to ensure top scientific and regulatory standards are met throughout drug development. The candidate will have opportunities to influence strategic direction and project delivery within this field.
Location and work setup
- Location
- Oslo
- Work setup
- On-site
Responsibilities
Lead and manage pharmacokinetic efforts supporting drug development, providing scientific and regulatory advice on drug metabolism and clinical pharmacology. Perform or oversee pharmacokinetic calculations, modeling, and analysis to guide development decisions. Coordinate and manage activities with Contract Research Organizations on behalf of clients. Oversee the preparation of pharmacokinetics-related documentation for regulatory submissions, including IMPDs, NDAs, and MAAs. Offer strategic input for regulatory interactions and submissions relating to pharmacokinetics.
Qualifications
PhD in a relevant scientific discipline with 5 to 10+ years of industry or regulatory experience in pharmacokinetics. Experience with multiple drug classes such as small molecules, biologics, peptides, oligonucleotides, ATMPs, or vaccines is advantageous. Skilled in pharmacokinetic modeling and simulation techniques including PKPD and PBPK. Proficient with WinNonlin software and Microsoft Office. Well-versed in global regulatory submission processes (e.g., IND, IMPD). Excellent communication and technical writing skills are required. Fluency in both a Nordic language and English is mandatory.