Pharmacometrics Senior Manager

Description

Leading quantitative and innovative strategies within clinical pharmacology to impact MIDD during the life cycle of the program

Evaluate and apply state-of-the-art quantitative pharmacology approaches for clinical pharmacology decision-making and for global regulatory submissions, including INDs, IBs, NDAs, BLAs, MAAs, and pediatric plans in collaboration with key stakeholders.

Evaluate and apply strategy and content as appropriate.

Guide dose regimen/optimization strategies in partnership with other therapeutic area leads and clinical pharmacology leads to enable data-driven decisions

Develop high-quality modeling and simulation strategy and content: author/review/approve modeling and simulation analysis plans and outputs, interpretation, and presentation of key findings to regulators and to stakeholders as needed.

Ensure adherence to agreed timelines and budgets to ensure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.

Develop and present training within and outside the department as needed

Qualifications

PhD or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 0+ years’ relevant pharmacometrics research or development experience OR

Masters or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 6+ years’ relevant pharmacometrics research or development experience OR

Bachelors or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 8+ years’ relevant pharmacometrics research or development experience.