at Merck in Dover, Delaware, United States
The Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development ( MIDD ) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced leadership team, deep modeling expertise and state-of-the-art modeling approaches across multiple therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management. The team is externally visible and continues to be at the leading edge of building innovative state of the art tools. With MIDD as an essential component of decision-making at ouor company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.
This Associate Director will work with scientists within QP2 by applying one or more of the following pharmacometrics capabilities such as population pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta analysis ( MBMA ), clinical trial simulations ( CTS ) and disease progression modeling into programs and thereby strengthening our pharmacometric capabilities on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author strategic documents.
Associate Directors are expected to have or be developing expertise in several areas, including: + Responsible for achieving results on major program drivers by implementation of one or more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions
+ Framing critical drug development questions for optimizing model-informed development
+ Responsible for developing and executing population pharmacokinetic models, PK/PD models, ER models, MBMA , CTS , disease progression models, and other pharmacometric analyses
+ Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings
Required Experience: + (a Ph.D. or equivalent degree with a minimum 3 years of experience) OR (a PharmD or equivalent degree with at least 5 years of experience) OR (an MS or equivalent degree with at least 7 years of experience), where "experience" means having a record of increasing responsibility and independence in a similar role 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 , etc
+ Knowledge of drug development, pharmacokinetics and pharmacology principles required
Preferred Experience: + Proficiency in performing MBMA , CTS in standard pharmacometric software (e.g. R, NONMEM , Monolix, Matlab, etc.)
+ Strong skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
+ Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning
+ Good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise
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