Director Pharmacometrics

Position: Director Clinical Pharmacology and Pharmacometrics (Pharmacometrician)

Location: Barcelona

**Typical Accountabilities**
- Accountable for expert data integration, analysis, interpretation, and reporting of PMx results at the project level
- Accountable for executing state-of-the-art PMx techniques with direct value for the project
- Use of PMx to influence study designs and go/no go decisions
- Scientific and strategic input into pre-clinical, clinical, and post-approval development plans
- Contribute to regulatory documents and interactions (oral/written)
- Presentation of pharmacometrics results in internal and external forum
- Contribute to internal initiatives to develop the pharmacometric discipline including its processes
- Participation in and accountability for peer review of ongoing activities, reports and presentations
- Supervision of modelling work performed by external contractors and more junior pharmacometricians, graduate students and post-doc
- Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance’s

**Required**:

- Significant demonstrated expertise within the field of PMx, including PK, PKPD and statistics
- Expert knowledge of PMx and Model-Informed Drug Development
- Demonstrated broad translational and clinical development expertise and experience exemplified by at least 6 years of drug development experience, with emphasis on pharmacometrics.
- Excellent oral and written communication skills
- Demonstrated ability to identify, develop and execute strategic pharmacometrics activities at the project level
- A demonstrated knowledge of regulatory, compliance, processes, standards and issues specific to pharmacometrics
- Relevant regulatory experience (written/oral)
- Skilled in relevant software and tools within the field of PMx
- Fluency in English (oral and written)
- PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required
- Relevant regulatory experience (written)
- Training and experience with PK and statistical software (NonMem, R, Stan, Monolix, or similar )

**Desirable**:

- International scientific reputation gained from scientific publishing in the field on pharmacometrics
- Experience in several organisations
- Expert knowledge in pharmacology, drug targets and core disease areas
- Good leadership capabilities, in particular with regards to influencing skills
- Experience with conducting submission ready pharmacometrics analyses
- Experience with concentration-QTc pharmacometrics analysis
- Management experience