Our clinical stage pipeline of novel ImmTACs continues to grow. We are looking for an excellent Clinical Pharmacologist. This position is responsible for efficiency, innovative, and timely clinical PK,PK/PD, and/or population PK study design, analysis, interpretation, and reporting of clinical studies to support program development and international regulatory submissions.
Key responsibilities are:
- Develop and implement clinical pharmacology plans for novel ImmTAC programs,
- Responsible for design, analysis, and communication of pharmacology strategy within and across clinical studies of novel ImmTAC programs,
- Perform pharmacokinetic analysis, interpretation, and reporting of data from clinical studies,
- Provide clinical pharmacology expertise/support in the preparation of regulatory submission (e.g. IB,IND,BLA) and Health Authority interactions.
- Effectively represents clinical pharmacology in cross-functional study-team settings,
- Works in close partnership with Clinical Development, Biomarkers, Bioanalytical, Project Management, Translational medicine and Medical Affairs functional areas to support clinical development programs
- Works closely with Pharmacometrician to generate detailed popPK and PK/PD modelling and simulations to determine optimal dosing strategies
- Contributes to clinical study design to establish effective PK sampling, biomarker data analyses and study endpoint correlations associated with exposure response assessments.
To be successful in this role, you must have:
- A strong experience in clinical pharmacology for oncology biological therapies,
- Experience as clinical pharmacology lead for BLA/MAA
- Significant demonstrated expertise in PK/PD design,analysis and statistics,
- Translational and clinical development experience exemplified by a significant number of years of drug development experience,
- Expert knowledge of pharmacokinetics,
- Demonstrated ability to identify, develop and execute strategic pharmacology activities at the project level,
PhD/PharmaD in clinical pharmacology; significant experience of pharmacology modelling and simulation in biopharma