Pharmacometrics CPQP

Essential Skills/Experience:

·        Significant demonstrated expertise within the field of modeling and simulation including PK, PKPD and statistics.

·        PhD degree or equivalent (M.Sc./Pharm.D.) required with relevant experience required.

·        Demonstrated broad translational and clinical development expertise and experience exemplified by at least 10 years international drug development experience (early and late), with emphasis on Pharmacometrics.

·        International scientific reputation gained from scientific publishing in the field on pharmacometrics.

·        Demonstrated ability to identify, develop and execute strategic M&S activities at level of portfolio.

·        Significant disease domain knowledge.

·        Relevant regulatory experience (written/oral).

·        A demonstrated knowledge of regulatory, compliance, processes, standards and issues specific to pharmacometrics.

·        Strong leadership capabilities, including influencing skills.

·        Experience in mentoring and developing others.

·        Expert knowledge about relevant software and tools within the field of M&S.