Job Description
The Senior Manager / Manager of Clinical Pharmacology in Clinical Pharmacology & Pharmacometrics (CPP) serves as the clinical pharmacology country lead on program, clinical pharmacology, and clinical study teams, providing strategic leadership and expertise in interpretation of clinical pharmacology data for drug candidates. He/she will integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to justify doses, dosage regimens for Japanese taking ethnic differences into consideration throughout clinical drug development.
Qualifications
- Minimum of 3 years (PhD) or 5 years (MSc) of experience working as a clinical pharmacologist, pharmacokineticist or pharmacometrician within biotech/ pharmaceutical industry.
- Demonstrates an understanding of 1) PK/PD principles, physiology, clinical pharmacology, and pathology; 2) operational and scientific aspects of early development studies; and 3) quantitative analysis.
- Ability to generate development strategies, design clinical pharmacology studies and analyze PK/PD data utilizing sound scientific principles. Ability to relate clinical pharmacology to the broader development paradigm
- Ability to generate electronic data submission package for Japan NDA submission
- Understanding and ability to apply appropriate regulatory and ICH guidelines in the design, analysis, and interpretation of clinical pharmacology studies
- Excellent oral and written communication skills for effective interactions in various environments including, but not limited to multidisciplinary teams, regulatory agencies, scientific symposia, advisory boards
- Knowledge of Health Authority perspective on clinical pharmacology and use of modeling and simulation.
Educational background:
- PhD degree in clinical pharmacology, pharmacokinetics, pharmacometrics, statistics, applied mathematics, or a related field. A MSc degree with relevant experience is also acceptable.
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
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