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Director/Sr. Director, Clinical Pharmacology
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Job Description
Position Responsibilities:
- Lead clinical pharmacology strategies across multiple programs at various stages of clinical development
- Execute modeling and simulation plans including PK/PD, population PK, and exposure-response analyses to guide clinical trial design, dose selection and optimization
- Develop clinical pharmacology plans to bridge IV to SC dosing
- Provide pediatric clinical pharmacology expertise and co-lead workstreams related to formulation development and sub-cutaneous route of administration
- Apply model-based drug development principles to answer key development questions enabling efficient drug development
- Contribute to preparation of regulatory documents and participate in discussions with Regulatory Agencies, with a focus on Model-informed Drug Development (MIDD).
- Contribute to clinical protocol design, study execution, data analysis, and writing clinical study reports
- Collaborate and mentor bioanalytical and translational team to develop comprehensive preclinical and clinical PK/PD strategy
Candidate Requirements:
- PhD in pharmacokinetics or pharmacology
- 7-10 years of experience in pharma/biotech industry, with proven track record of using clinical pharmacology to guide clinical trial/dosing decision
- Proficient knowledge and hands-on experience in all aspects of clinical pharmacology, including modeling and simulation of pharmacokinetic, pharmacodynamic, and efficacy relationships, including expertise with population modeling
- Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, toxicology assessing the clinical relevance
- Experience in subcutaneous drug development and IV to SC bridging is highly desired
- Strong interpersonal skills to work effectively in a team setting/matrix-type organization
- Understands the drug development process from pre-IND through BLA
- Highly organized, outcome-oriented, self-motivated performer
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