What You’ll Do: The Director will serve as Pharmacometrics Lead and Clinical Pharmacology Lead for clinical studies. The successful candidate will play a critical role in shaping the clinical strategy by applying scientific expertise in PK and PD and utilizing quantitative tools to inform the dosing regimen that optimizes the therapeutic index of investigational drugs across all stages of clinical development. In this role you will work in the clinical development division and collaborate with colleagues across functions such as clinical, clinical operations, biometrics, regulatory, and medical affairs.

Responsibilities:

• Participate in clinical projects teams to move forward new drug candidates from pre-IND through submission
• Contribute to design of Phase 1, 2 and 3 studies and associated clinical documents and reports
• Analysis, interpretation, and reporting of clinical PK and PD results
• Responsible for scientific justification of clinical dose selections
• Contribute to regulatory submissions and interactions with Health Authorities

Qualifications:

• PhD degree in Pharmaceutical Sciences or related field.
• Trained in Pharmacokinetics, Pharmacodynamics and Drug Metabolism
• At least 5 years of experience in clinical drug development of small molecules
• Recent PK and PK/PD modelling skills using NONMEM
• Experience with MIDD paired meeting program
• Excellent communication and presentation skills
• Excellent publication record

Location:  Burlington, MA or Redwood City, CA offices, this will be a hybrid position on-site three days per week.