Associate Director Clinical Data Management Jobs in Delaware

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

Job Summary (Primary function)

We are seeking a pharmacometrician to join our Clinical and Quantitative Pharmacology organization in Translational Medicine. An Associate Director is responsible for executing on the pharmacometrics strategy and model-based analyses for clinical drug development and is expected to play a key role in supporting programs. This role will be responsible for developing and implementing model-informed drug development (MIDD) strategies to optimize decision-making across all phases of drug development.

Essential Functions of the Job (Key responsibilities)

• Responsible for independently conducting and reporting model-based analyses including population pharmacokinetics (PK) and pharmacokinetics/pharmacodynamics (PK/PD), exposure-response modeling, model-based meta-analyses (MBMA), disease progression modeling, and clinical trial simulation.
• Identifies opportunities where modeling and simulation can advance the understanding of pharmacokinetics, pharmacodynamics, efficacy, and safety across multiple projects
• Accountable for developing MIDD strategies across multiple programs and disease areas to optimize prospective studies, inform the overall clinical development and regulatory strategies in collaboration with partners (clinical pharmacology, biostatistics, regulatory, and clinical development teams)
• Effectively communicates results, conclusions, and assumptions of pharmacometrics analyses to a variety of audiences to influence the decision-making process (written and oral presentation)
• Mentors and guides peers in pharmacometrics methodologies, tools, and their application in clinical drug development
• Stays current with scientific advancements and regulatory trends in clinical pharmacology and pharmacometrics, and applies the knowledge to advance drug development for the organization
• Publishes in peer-reviewed journals

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Ph.D. in Pharmacometrics, Clinical Pharmacology, Applied Mathematics, Statistics, Engineering, or a related field.
• Demonstrated 3-5 years of related industry experience.
• Hands-on experience in a statistical programming language and pharmacometrics analysis software including R and NONMEM or equivalents
• Excellent communication skills and ability to collaborate with cross-functional teams
• Time management and ability to balance execution of multiple tasks to accomplish program goals.

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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