Merck
Director, Pharmacometrics
Merck, Saint Paul, Minnesota, United States, 55199
Director – Pharmacometrics,
Quantitative Pharmacology and PharmacometricsThe 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. This position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of pharmacometricians.The Director-Pharmacometrics will work with scientists within QP2 by proactively evaluating and incorporating advanced pharmacometrics capabilities like comparator modeling, model-based meta-analysis (MBMA) and clinical trial simulations (CTS) into programs. The Director will develop and deploy comparator models across different therapeutic areas and will be accountable for coaching/mentoring talented pharmacometricians.Responsibilities:Achieve results on major program deliverables by identifying, driving the development and implementation of novel quantitative approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions.Serve 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 programs.Mentor and/or supervise junior colleagues to perform the above duties and develop capabilities.Leverage significant pharmacometric and subject matter expertise in a broad range of therapeutic areas, modalities and stages of drug discovery/development to provide day-to-day coaching/guidance to individual contributors.Required Experience:Ph.D. or equivalent degree with at least 7 years of experience OR a PharmD or equivalent degree with at least 9 years of experience OR an MS or equivalent degree with at least 11 years of experience in pharmaceutical drug development or academia.Educational background in pharmacometrics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.Extensive experience in performing pharmacometrics analyses such as MBMA and CTS using standard pharmacometric software (e.g. NONMEM, R, Monolix, etc.).Deep expertise in pharmacometrics and understanding how MIDD can drive portfolio and regulatory decisions.Deep knowledge of drug development, pharmacokinetics and pharmacology principles.Preferred 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 planning.Strong interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise.Excellent communication skills including ability to effectively present complex data, development plans and strategies to various audiences in both verbal and written form.Demonstrated external visibility in the field of pharmacometrics through publications, presentations, and involvement in professional organizations.Ability to participate in and steer an interdisciplinary team, and oversee the work of other scientists.
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Quantitative Pharmacology and PharmacometricsThe 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. This position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of pharmacometricians.The Director-Pharmacometrics will work with scientists within QP2 by proactively evaluating and incorporating advanced pharmacometrics capabilities like comparator modeling, model-based meta-analysis (MBMA) and clinical trial simulations (CTS) into programs. The Director will develop and deploy comparator models across different therapeutic areas and will be accountable for coaching/mentoring talented pharmacometricians.Responsibilities:Achieve results on major program deliverables by identifying, driving the development and implementation of novel quantitative approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions.Serve 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 programs.Mentor and/or supervise junior colleagues to perform the above duties and develop capabilities.Leverage significant pharmacometric and subject matter expertise in a broad range of therapeutic areas, modalities and stages of drug discovery/development to provide day-to-day coaching/guidance to individual contributors.Required Experience:Ph.D. or equivalent degree with at least 7 years of experience OR a PharmD or equivalent degree with at least 9 years of experience OR an MS or equivalent degree with at least 11 years of experience in pharmaceutical drug development or academia.Educational background in pharmacometrics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.Extensive experience in performing pharmacometrics analyses such as MBMA and CTS using standard pharmacometric software (e.g. NONMEM, R, Monolix, etc.).Deep expertise in pharmacometrics and understanding how MIDD can drive portfolio and regulatory decisions.Deep knowledge of drug development, pharmacokinetics and pharmacology principles.Preferred 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 planning.Strong interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise.Excellent communication skills including ability to effectively present complex data, development plans and strategies to various audiences in both verbal and written form.Demonstrated external visibility in the field of pharmacometrics through publications, presentations, and involvement in professional organizations.Ability to participate in and steer an interdisciplinary team, and oversee the work of other scientists.
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