Job Summary (Primary function)
Essential Functions of the Job (Key responsibilities)
Be responsible for the design and interpretation of PK studies necessary for the selection of clinical candidates.
Ensure adequate PK characterization and liability assessment to support candidate nomination and clinical dose projections.
Responsible for writing PK and TK reports, and author PK sections for regulatory submissions and IB updates.
Develop interdisciplinary collaborations and ensure that key PK data, information, and priorities are integrated into overall project team strategy.
Qualifications (Minimal acceptable level of education, work experience, and competency)
PhD or equivalent with 3+ years of industry experience in PK.
A strong working knowledge of antibody pharmacokinetics with hands on experience using PK software packages is preferred. Knowledge and expertise in modeling such as PBPK and PK/PD is a desirable plus.
A broad knowledge of antibody clearance mechanisms and antibody bioanalytical techniques is preferred.
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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During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
