Assoc Dir - Dir, Bioanalytical And Clinical PK

JOB SUMMARY:

The successful candidate will act 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.  

ESSENTIAL DUTIES AND 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

EDUCATION/KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

• PhD in pharmacokinetics, drug metabolism, pharmaceutical sciences, analytical chemistry or closely related discipline with a minimum of 6 years 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