Senior Bioanalytical Clinical PK Representative
1 week ago
The successful candidate will serve as the bioanalytical clinical PK representative across multiple oncology projects at the discovery and IND-enabling stages of development. The individual will provide support to fast-paced cross-functional teams in the design, execution, analysis, reporting, and troubleshooting of DMPK assays and assay data.
Key Responsibilities- Design, execute, and troubleshoot clinical pharmacology studies with CROs to support internal discovery groups.
- Analyze, interpret, report, and present DMPK/ADME data at internal program meetings.
- Identify and maintain close relationships with CROs that conduct a range of in silico, in vitro, and in vivo studies.
- Perform pharmacokinetic and pharmacodynamic modeling and simulation using software such as WinNonlin or R.
- Provide oversight for DMPK/clinical pharmacology-related sample management activities, including management of BA CROs.
- Contribute to the preparation of bioanalytical sections of IND/BLA documents.
- Attend project meetings and manage timelines for coordinating BA and CRO work.
- Responsible for review and approval of data/report from both BA and CRO labs in coordination with the CRO BA PI and PM.
- Lead scientific review and provide instructions on bioanalysis at CROs to provide quality data/reports within specified timelines.
- Supervise, manage, and strategic planning on objectives and prioritization with BA CROs to deliver robust and reliable bioanalytical assays.
- Independently perform PK/PD analysis, IVIVCs, DDI risk assessments, human dose projections.
- Contribute to authoring, editing, and review of documents for regulatory submissions.
- Independently manage workload and expectations according to company portfolio priorities.
- Other duties and projects as assigned.
- PhD in pharmacokinetics, drug metabolism, pharmaceutical sciences, analytical chemistry, or closely related discipline with a minimum of 6 years of experience in biotech/pharmaceutical field or MS with 8 to 12 years of experience in leading and managing a bioanalytical function within a corporate setting.
- Extensive understanding of DMPK/ADME concepts and application in drug development settings, including but not limited to IVIVC, DDI risks, PK/PD assessment, dose projections, etc.
- Ability to effectively interact with cross-functional teams consisting of project management, medicinal chemists, biologists, pharmacologists, toxicologists, regulatory, and clinical.
- Proactive, innovative, superb problem-solving skills, and willingness to improve upon existing strategies.
- In-depth knowledge of bioanalytical methods to assess PK and disposition of small molecules.
- This candidate should be a driver of innovative scientific research and development on bioanalysis.
- Experience in writing and reviewing validation/bioanalytical reports for regulatory filing.
- In-depth knowledge of ICH and health authority guidances.
- Experience in providing DMPK support to regulatory teams, including co-authoring of documents, for INDs, CTAs, NDAs, beneficial but not required.
- Demonstrated ability to effectively manage CROs.
- Proficient in using latest analysis and modeling software.
- Excellent oral, written, and presentation skills with the ability to stay organized across multiple projects.
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