Quantitative Clinical Pharmacologist

Responsibilities:

1. Provides scientific and strategic leadership as the Clinical Pharmacology Lead for multiple programs on Global Program Teams and associated scientific and operational sub-teams.
2. As appropriate, effectively partner with clinical, biostatistics, data manage, and regulatory departments, creates or assists in the preparation of protocol synopses, oversees program execution including protocol conduct, data analysis and reporting.
3. Responsible for clinical pharmacology summary documents for regulatory submissions (such as IB, CTA, CTD Module 2 documents, product labeling).
4. 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.

Qualifications and experience:

1. Master or Ph.D degree in pharmacy, pharmaceutics, pharmacokinetics, pharmacometrics, engineering disciples, and related fields.
2. 1-3 years of experience in academia, pharmaceutical industry or regulatory agency.
3. Good understanding of pharmacokinetic/pharmacodynamic principles and drug development
4. Experience representing application of quantitative clinical pharmacology in drug development and hands-on experience.
5. Proficiency in R programming, and PK software like NONMEM, Monolix, Phoenix, or similar.
6. Strong written and oral communication skills and interpersonal skills.
7. Working on-site on Boston MA