Associate Director Quantitative Pharmacology and Pharmacometrics Cardiometabolic and Ophthalmic Diseases

Job Description

The Quantitative Pharmacology and Pharmacometrics (QP2 Department of our Companys Research Laboratories in West Point PA / Rahway NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines.

As an Associate Director you will represent QP2 on crossfunctional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for cardiometabolic and ophthalmologic diseases. You will work on the discovery and development of small molecules biologics and nontraditional therapeutics like peptides novel biological constructs and others. The Associate Director is a skilled quantitative drug developer with a strong integrated understanding of the strategic elements of drug discovery and development. The Associate Director should demonstrate collaborative work spirit and excellent communication skills and should work independently with minimal supervision.

Within QP2 you have a unique opportunity to accelerate your professional career as a quantitative drug developer taking advantage of our endtoend pipeline support in one of the worlds most researchintensive biopharmaceutical companies.

Responsibilities:

• Develop modelbased strategies translational PK/PD strategies mechanistic model POPPK/PD clinical trial simulations etc) for quantitative analyses within and across development programs and/or departments to inform and optimize drug discovery and all phases of drug development including but not limited to dose selection clinical trial design and go/nogo decisions.

• Represent QP2 on cardiometabolic and ophthalmology discovery early clinical development and late clinical development teams leveraging quantitative approaches to drive streamlined development of programs within our growing ophthalmology portfolio.

• Collaborate with other functional areas as well as with external vendors and partners creating an aligned quantitative and modelinformed regulatory framework to impact strategies and decisions of drug discovery and development teams.

• Collaborate with other functional areas as well as with external vendors and partners on activities related to study design protocol development study reporting and interpretation of data.

• Maintain a comprehensive understanding of global regulatory expectations and shape present and defend regulatory documents and submissions.

• Work closely with pharmacometrics team members and provides input related to analysis and reporting of modeling activities.

Required:

• A Ph.D. or equivalent degree with at least 4 years of experience OR a PharmD or equivalent degree with at least 6 years of experience OR an MS or equivalent degree with at least 8 years of experience where experience means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development regulatory agency or academia.

• Educational background in biopharmaceutics pharmaceutical sciences pharmacometrics chemical/biomedical engineering or a related field.

• Experience in performing population PK/PKPD analyses using standard pharmacometrics software (e.g. NONMEM Monolix Phoenix etc.

• Proficiency in written and verbal communication interdisciplinary collaboration and problem scoping and planning.

• Knowledge in modeling of complex therapeutics.

Preferred:

• Knowledge in cardiometabolic and/or ophthalmology clinical drug development programs

• Expert skills in experimental design mathematical problem solving critical data analysis/interpretation and statistics.

• Scientific understanding of biopharmaceutical and ADME properties of small molecules and/or biologics

• An exemplary record of increasing responsibility independence and demonstrated impact in driving drug development decisions through application of modelbased approaches.

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Expected US salary range:

Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.

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