Senior Scientist, Pharmacology
- Cambridge, MA
- Department: Research & Development
- Region: US
The Senior Scientist, Clinical Pharmacologist is responsible for the clinical pharmacology and pharmacometric deliverables for clinical development assets from phase I-III. The responsibilities include 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. He/She contributes to evaluating various clinical pharmacology and modeling strategies and building clinical pharmacology and pharmacometrics infrastructure. The Senior Scientist, clinical pharmacologist serves as Clinical Pharmacology Lead on programs with high quantitative intensity and will collaborate closely with Clinical Pharmacology on advanced pharmacology models.
· Under supervision, drives the development and execution of the Quantitative Pharmacology and Pharmacometric Strategy of clinical development teams. Also support regulatory responses related to clinical pharmacology and pharmacometrics.
· Under supervision, drives the development and execution of the Quantitative Pharmacology and Pharmacometric Strategy of clinical development teams. With appropriate supervision leads 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. Analyzes results, interprets, and recommends action based on study results
· Performs advanced quantitative pharmacology and pharmacometric analyses and activities within assigned programs to yield high value PK/PD support for critical decisions and dose selection. Interprets and presents results and recommends appropriate actions.
· Develops and maintains strong knowledge of best regulatory practices, clinical pharmacology principles, PK/PD analysis methodology and drug development precedent.
· Develops and maintains scientific awareness and presence in Quantitative Pharmacology and Pharmacometric Science, publishes manuscripts and posters, presents at Scientific Conferences and other scientific forums.
· Minimum of 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.
PhD degree in clinical pharmacology, pharmacy, biomedical engineering, statistics, applied mathematics, or a related field. A MSc degree with relevant experience is also acceptable.
The Clinical Pharmacologist serves as the clinical pharmacology and pharmacometrics lead on clinical study management teams providing execution of development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics and drug metabolism (PPDM) of the drug candidate in selected preclinical and all clinical areas.