Apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications
Job Summary
Apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications.
Develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions, demonstrating outstanding leadership and communication skills.
This role will be focused on efforts in the infectious disease and vaccines therapeutic area, with a salary range of $190,800.00 - $300,300.00, eligibility for annual bonus and long-term incentive, and a comprehensive benefits package.
Matching Summary
Apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications.
Salary
Base: $190,800.00 - $300,300.00; Bonus/Equity: Annual bonus and long-term incentive; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
Quantitative PK/PD modeling
Model-based drug development
Regulatory strategy and submissions
Infectious disease and vaccine assets
Exposure-response modeling
Clinical trial design simulation
Nice-to-have
Leadership and communication skills
Mentoring junior colleagues
Cross-functional collaboration
External vendor and partner management
Key Requirements
Ph.D. or equivalent degree with at least seven years of experience
PharmD or equivalent degree with at least nine years of experience
Experience with modeling programming languages
Direct experience in regulatory interactions and filings