Principal Investigator / Associate Director
Wilmington, DE, USA | Incyte Corporation
Industry:Pharmaceutical / Biotech
Job Description:99 people have viewed this job
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)
Our DMPK group is seeking a highly motivated and well accomplished DMPK project lead to provide strategic DMPK support to the discovery and nonclinical development of small molecule and biologics drugs. The selected individual will be an integral project team member representing DMPK on small molecule and biologics research projects to ensure effective integration of ADME, PK and PKPD into the team strategy.
Serve as a DMPK project lead on discovery and development 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 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 and TK 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.
PhD or equivalent with 5+ years of industry experience in DMPK
A strong working knowledge of pharmacokinetics with hands on experience using PK software packages is required. Knowledge and expertise in modeling such as PBPK and PK/PD is a desirable plus. PK knowledge and experience on biologics is a plus.
A broad knowledge of drug-drug interactions, metabolizing enzymes, clearance mechanisms, absorption, transporters, and bioanalytical techniques is required
Experience as a DMPK project lead in discovery programs is desirable.
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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