Associate Director, Quantitative Clinical Pharmacology (qcp) Lead

Takeda

Boston, MA, United States
Base: $154,400.00 - $242,550.00; bonus/equity: not...
On-site
Clinical pharmacology strategy
Model-informed drug development (midd)
Pk/pd data integration
Lead strategic, scientific, and operational aspects of multiple drug development projects from first in human dosing through life cycle management

Job Summary

  • Lead strategic, scientific, and operational aspects of multiple drug development projects from first in human dosing through life cycle management.
  • Integrate pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations.
  • Represent Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions.

Matching Summary

Lead strategic, scientific, and operational aspects of multiple drug development projects from first in human dosing through life cycle management.

Salary

Base: $154,400.00 - $242,550.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 401(k), paid time off, and more

Skills & Requirements

Must-have

  • clinical pharmacology strategy
  • Model-Informed Drug Development (MIDD)
  • PK/PD data integration
  • regulatory submissions
  • scientific leadership

Nice-to-have

  • patient-focused innovation
  • collaborative workplace
  • advanced analytics
  • external scientific community engagement

Key Requirements

  • Pharm D. or PhD with 5+ years experience
  • MS with 8+ years experience
  • clinical pharmacology responsibilities
  • drug development process expertise
  • regulatory guidance knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter