Associate Director, Quantitative Pharmacology and Pharmacometrics Cardiometabolic and Ophthalmic Diseases (Hybrid or Remote)

Merck KGaA Darmstadt Germany • Rahway, NJ

117d

About The Position

The Quantitative Pharmacology and Pharmacometrics (QP2) Department of our Company's 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 cross-functional 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 non-traditional 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 end-to-end pipeline support in one of the world's most research-intensive biopharmaceutical companies.

Requirements

• 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.

Nice To Haves

• 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 model-based approaches.

Responsibilities

• Develop model-based 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/no-go 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 model-informed 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 execution, 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 provide input related to analysis and reporting of modeling activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree