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Form of workJob Description
Summary
The Associate Director, Clinical Pharmacology will be a key member and will report directly to the VP of Clinical Pharmacology. This individual will apply strong pharmacometrics skills to independently determine, plan, and execute modeling and simulation analyses.
Responsibilities
- Serve as a core member of cross-functional drug development teams
- Serve as the lead for pharmacometrics deliverables, including population PK, PK-PD, exposure-response, model-based meta-analysis, trial simulation, etc.
- Participate in the preparation of regulatory responses and submissions, interactions with health authorities as pharmacometrics subject matter expert (SME)
- Collaborate with internal and external SMEs to develop and enhance pharmacometrics methodologies and capabilities
- Be responsible for guiding model-based efficacious dose prediction for First-In-Human studies by interpreting and integrating in vitro and in vivo data from nonclinical studies.
Qualifications
- Ph.D. degree in life sciences (e.g., biology, biochemistry, biophysics, or pharmacology), chemical engineering, pharmacokinetics, or related disciplines with 7+ years relevant experience in PK/PD, systems pharmacology, and mathematical modeling
- 7+ years of Pharmaceutical or Biotech experience
- Experience with the development of small molecules required
- Experience with pediatric development is a plus
- Expertise with modeling software including NONMEM, R, etc. Experience with PBPK modeling is a plus
- A strong understanding of the US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP
- Excellent verbal, presentation, and written communication skills
- Demonstrated understanding of CMC, translational biomarkers, drug metabolism & transporters, pharmacokinetics, and drug development
- Ability to foster relationships within an organization and advance the concepts of model-informed drug development (MIDD)
- Record of publications, presentations, and volunteering for professional organizations
