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Merck

Director, Pharmacometrics

Merck, Helena, Montana, us, 59604


Director – Pharmacometrics,

Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to enable efficient drug discovery/development and regulatory decisions. The Pharmacometrics group within QP2 brings experienced leadership, deep modeling expertise, and state-of-the-art approaches across therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management. The team is visible externally and at the forefront of building innovative tools. This position offers the Director an opportunity to drive pipeline impact and mentor a talented group of pharmacometricians.The Director-Pharmacometrics will work with scientists within QP2 by evaluating and incorporating advanced pharmacometrics capabilities like comparator modeling, model-based meta-analysis (MBMA), and clinical trial simulations (CTS) into programs to strengthen pharmacometric capabilities continuously. The Director will independently develop and deploy comparator models across therapeutic areas and mentor talented pharmacometricians to drive portfolio impact.Directors (Pharmacometrics) are expected to provide expertise in pharmacometrics capabilities through the following responsibilities:Responsible for achieving results on major program deliverables by identifying and implementing novel quantitative approaches to improve cycle time, cost, number of trials, clinical trial design, and Go/No Go decisionsServe as a subject matter expert and foster collaboration within QP2 and across functions to plan and execute novel analyses such as MBMA for informed decision making on programsMentor and supervise junior colleagues to perform duties and develop capabilitiesLeverage pharmacometric and subject matter expertise to provide day-to-day coaching to individual contributorsRequired Experience:(Ph.D. or equivalent with at least 7 years of experience) OR (PharmD or equivalent with at least 9 years of experience) OR (MS or equivalent with at least 11 years of experience), where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academiaEducational background in pharmacometrics, pharmaceutical sciences, mathematics, statistics, computational biology, chemical/biomedical engineering, or related fieldExtensive experience in performing pharmacometrics analyses such as MBMA and CTS using standard pharmacometric software (e.g., NONMEM, R, Monolix, etc.)Deep expertise in pharmacometrics with the ability to understand how MIDD can drive portfolio and regulatory decisionsDeep knowledge of drug development, pharmacokinetics, and pharmacology principlesPreferred Experience:Experience in performing pharmacometric analyses such as population pharmacokinetics (PopPK), pharmacokinetic/pharmacodynamic models, exposure-response models using NONMEM, R, Monolix, etc.Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planningStrong interpersonal skills for teamwork and productive interactions among diverse personalities/areas of expertiseExcellent communication skills including presenting complex data, development plans, and strategies to various audiences in verbal and written formDemonstrated external visibility in pharmacometrics field through publications, presentations, and involvement in professional organizationsAbility to participate in and steer an interdisciplinary team and oversee the work of other scientists

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