Associate Scientific Director, Clinical Pharmacology
New
B
BiogenBiotechnology
The candidate must reside within the USA.Full-TimeSenior
Salary$144,000.00-$240,000.00
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Job Details
- Experience
- 5+ years relevant industry experience
- Required Skills
- R
Requirements
- PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields.
- 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD).
- Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles.
- Experience with designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies.
- Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm.
- Knowledge of and ability to apply appropriate regulatory and ICH guidelines.
- Hands-on experience with developing and implementing Quantitative Systems Pharmacology (QSP) models, and/or population PK, PKPD, exposure-response analyses.
- Proficiency with use of PK/PD software packages such as Phoenix, R, NONMEM.
- Excellent oral and written communication skills.
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, considering strategic, scientific, translational, and clinical aspects.
- Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies.
- Lead execution of clinical pharmacology studies and analyses, interpret results, and recommend actions.
- Conduct hands-on quantitative analysis and present findings to multidisciplinary project teams.
- Serve as lead author and key contributor to clinical pharmacology sections of documents.
- Serve as the subject matter expert in interactions with Health Authorities.
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