at Incyte Corporation in Wilmington, Delaware, United States
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.
Our clinical PK group is seeking a seasoned and well-accomplished clinical pharmacologist/pharmacometrician to provide strategic clinical PK support to the clinical development of small molecule and biologics drugs. The selected individual will be an integral project team member working in clinical development matrix teams to ensure effective integration of model informed drug development strategy into the global development plan.
We have flexibility to hire at different levels depending on a candidate's experience and skill set.
Represent clinical PK on clinical project teams and be responsible for all aspects of clinical PK and model informed drug development strategy and implementation for assigned projects
Work closely with study team members including clinicians, translational scientists, regulatory, biostatisticians and etc. to provide pharmacometric deliverables on time
Design and conduct pharmacometric analysis including population PK/PD analysis, PBPK modeling, simulation-based trial design and dose selection, author pharmacometric data analysis plans and reports, and communicate results to clinical teams and management in a timely manner
Write/review sections of drug development and registration documents such as clinical trial protocols and reports, investigator brochures and regulatory submission packages.
Provides clinical pharmacology support and leadership in written/face-to-face interactions with regulatory authorities and address regulatory queries and labeling requests in connection with submission.
Develop interdisciplinary collaborations and ensure that key pharmacometric data, information, and priorities are integrated into overall project team strategy.
Present work at internal and external scientific meetings and publish manuscripts in peer-reviewed journals.
PhD or equivalent with 5+ years of industry experience in clinical pharmacology and pharmacometrics field.
Thorough understanding of pharmacokinetics and pharmacodynamics concepts and modeling approaches with a broad understanding of biopharmaceutical and ADME properties of both small molecules and biologics
Proficient in multiple software packages such as Phoenix, R, NONMEM, Monolix, MatLab, Simcyp, GastroPlus, or other pharmacokinetic, modeling and data visualizations software.
Experience in representing clinical pharmacology in clinical development programs and understanding of model-informed drug development strategies
Record of significant and successful contributions to regulatory submissions, such as CTAs and/or NDA/sNDA/MAA, and other regulatory agency interactions is a plus
Excellent oral and written communication skills along with effective organizational and collaboration 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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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