- Serve as a PK project lead on antibody discovery project teams. Initiate and engage in multifunctional collaborations to facilitate the advancement of drug candidates and build thorough knowledge of drug candidate properties.
- 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.
- 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.
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Sr. Research Investigator/Principal Investigator, Antibody PK - Wilmington, United States - InCyte
Description
Overview
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity.
Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.Job Summary (Primary function)
This position will provide strategic PK support to the discovery and nonclinical development of antibody drugs.
The selected individual will be an integral project team member representing PK on antibody research projects to ensure effective integration of PK and PKPD into the team strategy.
Essential Functions of the Job (Key responsibilities)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.Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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