Job Responsibilities:
- Serve as a DMPK project lead on discovery project teams. Initiate and engage in multifunctional collaborations to facilitate the advancement of drug candidates and build thorough knowledge of drug candidate properties.
- Responsible for the design and interpretation of preclinical DMPK studies necessary for the selection of clinical candidates.
- Ensure adequate characterization and liability assessment to support candidate nomination and clinical dose projections.
- Responsible for writing PK reports, and author DMPK sections for regulatory submissions and IB updates.
- Develop interdisciplinary collaborations and ensure that key DMPK data, information, and priorities are integrated into overall project team strategy.
Minimum Requirements
- PhD or equivalent with 5+ years of industry experience in PK.
- Strong working knowledge of ADME (in vitro, in vivo, in vitro-to-in vivo) and pharmacokinetics with hands-on experience using PK software tools (e.g., WinNonlin, Gastroplus) is required. Knowledge and expertise in modeling such as PBPK and PK/PD is preferred.
- Experience as a DMPK project lead in discovery programs is preferred.
- PK knowledge and experience with biologics and protein degraders is a desirable plus.
- Appropriate understanding of applicable FDA and European regulations with experience in IND filing and clinical protocols is a plus
- Excellent oral and written communication skills are essential along with strong organizational skills.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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