Job Description

• Will serve as a SME expert in DMPK and ADME on project teams among other departments to progress drug development programs
• Will design PKPK, PK, and TK studies
• Will conduct data analysis and also manage CRO partners in outsourced studies
• Represents the function at internal and external meetings, ensures adherence of timelines, data, and impact to pipeline assets, including complex visualizations, to effectively communicate.
• Collaborates with internal research and translational teams
• Contribute to relevant sections of of regulatory submissions and clinical protocols (e.g. INDs, IBs, CTDs, BLAs).

Qualification

• Ideally a PhD and 6+ years of industry experience (AD level), more for Director, with experience in the DMPK/ADME function
• MS level candidates with significant industry experience can also be considered.
• Experience with various drug modalities such as small molecules, large molecules, mRNA, or ADCs, is required.
• Experience in the submission of global filings (IND/NDA/BLA).
• Excellent problem solving and communication skills

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