Biogen Principal Scientist, Clinical Pharmacology in Cambridge, Massachusetts
About This Role As the Principal Scientist, Clinical Pharmacology & Pharmacometrics, you will be responsible for the clinical pharmacology and pharmacometrics deliverables for clinical development assets from phase I-III and developing a clinical pharmacology plan and dose selection and prediction using mathematical and statistical models to study complex interactions between drug and patients, between biological systems and to understand disease progression and impact of patient stratification on disease progression. You will contribute to evaluating various clinical pharmacology and modeling strategies and building clinical pharmacology and pharmacometrics infrastructure. What you'll Do * Serve as Clinical Pharmacology Lead on programs with high quantitative intensity and will collaborate closely with Clinical Pharmacology on advanced pharmacology models. * Assist in driving the development and execution of the Quantitative Pharmacology and Pharmacometric Strategy of clinical development teams. * Support regulatory responses related to clinical pharmacology and pharmacometrics. * Lead preclinical and clinical pharmacology study efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, and reporting) within assigned programs to yield high value PK/PD/DM insight for future critical decisions. * Analyze results, interprets, and recommends action based on study results * Perform advanced quantitative pharmacology and pharmacometric analyses and activities within assigned programs to yield high value PK/PD support for critical decisions and dose selection. * Interpret and present results and recommends appropriate actions. * Develop and maintain strong knowledge of best regulatory practices, clinical pharmacology principles, PK/PD analysis methodology and drug development precedent. * Develop and maintain scientific awareness and presence in Quantitative Pharmacology and Pharmacometric Science, publish manuscripts and posters, present at Scientific Conferences and other scientific forums. Required Skills: * * PhD degree in clinical pharmacology, pharmacy, biomedical engineering, statistics, applied mathematics, or a related field. MSc degree with relevant experience is also acceptable. * 3+ years (PhD) or 5+ years (MSc) of experience working as a clinical pharmacologist, DMPK or pharmacometrician within biotech/ pharmaceutical industry. * Experience developing advanced PK/PD models to aid in research and development decision making. * Knowledge of Health Authority perspective on clinical pharmacology and use of modeling and simulation. *Preferred Skills: * * Experience with use of PK/PD software packages such as Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS *Why Biogen Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.