Associate Scientific Director
New
The candidate must reside within the USA.Full-TimeManager
Salary$144,000.00-$240,000.00
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Job Details
- Experience
- 5+ years
- Required Skills
- R
Requirements
- PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields
- 5+ years relevant industry experience in clinical pharmacology and/or clinical PK/PD
- Ability to analyze and interpret PK and PK/PD data
- Experience with designing and implementing clinical studies and/or dedicated Clinical Pharmacology studies
- Knowledge of regulatory and ICH guidelines
- Hands-on experience with Quantitative Systems Pharmacology (QSP) models, population PK, PKPD, or exposure-response analyses
- Proficiency with PK/PD software packages such as Phoenix, R, NONMEM
Responsibilities
- Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle
- Identify opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy and safety
- Develop and implement the clinical pharmacology development plan
- Define key milestones and decisions and identify risks and mitigation strategies
- Lead execution of clinical pharmacology studies and analyses
- Conduct hands-on quantitative analysis and present findings
- Serve as lead author on clinical pharmacology documentation
- Serve as subject matter expert in interactions with Health Authorities
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