Associate Director of Pharmacometrics, Quantitative Pharmacology & Pharmacometrics

$149,400 - $235,100/Yr

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Associate Director in the Quantitative Pharmacology and Pharmacometrics (QP2) department will drive model-informed drug discovery and development (MIDD) to enhance drug discovery and regulatory decisions. This role involves applying pharmacometrics capabilities to strengthen decision-making processes and pipeline impact across various therapeutic areas. The Associate Director will work independently and lead efforts on drug/vaccine development programs, authoring strategic documents and ensuring the implementation of novel quantitative approaches to optimize drug development processes.

Responsibilities

• Drive pipeline impact across therapy areas by applying pharmacometrics capabilities.
• Develop and execute population pharmacokinetic models, PK/PD models, ER models, MBMA, CTS, and disease progression models.
• Frame critical drug development questions to optimize model-informed development.
• Author and co-author regulatory documents (INDs, CSRs, CTDs) and represent QP2 at regulatory meetings.
• Achieve results on major program drivers by implementing novel quantitative approaches.

Requirements

• Ph.D. or equivalent degree with a minimum of 3 years of experience, or a PharmD with at least 5 years of experience, or an MS with at least 7 years of experience in pharmaceutical drug development or academia.
• Educational background in pharmacometrics, biopharmaceutics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
• Proficiency in performing pharmacometrics analyses such as population PK, PKPD, ER, MBMA, CTS.

Nice-to-haves

• Proficiency in standard pharmacometric software (e.g. R, NONMEM, Monolix, Matlab).
• Strong skills in experimental design, mathematical problem solving, and critical data analysis/interpretation.
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days