Principal Scientist - Pharmacokinetics, Pharmacodynamics, and Drug Metabolism (Remote)

Job Description

The Quantitative Pharmacology and Pharmacometrics (QP2) department within Pharmacokinetics, Pharmacodynamics, and Drug Metabolism (PPDM) drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 has the opportunity to work on an exciting pipeline with multiple modalities across multiple therapeutic areas at all stages of drug discovery and development and brings deep modeling expertise leveraging state-of-the-art modeling approaches. The team is externally visible and continues to be at the leading edge of building innovative state-of-the-art tools. The Principal Scientist in the Pharmacometrics group will primarily apply quantitative approaches to develop and implement M&S strategies for the discovery and development of biologics and novel therapeutics including ASOs, ADCs, cell, gene therapies and RNA therapeutics.

Principal Scientists in QP2 perform job duties independently with minimal supervision, and mentor others to develop similar capabilities. The Principal Scientist should provide strategic leadership through the following responsibilities:

• Leverages pharmacometric principles to emerging therapeutics including multi-specifics, fusion proteins, ASOs, ADCs, RNA therapeutics, cell/gene therapeutics

• Implements fit-for-purpose or mechanistic/QSP models for early discovery decisions including affinity maturation, modality selection decisions in close collaboration with pharmacologists, preclinical and protein scientists

• Framing critical drug development questions for optimizing model-based development

• Developing and executing translational PK/PD models, population pharmacokinetic models, exposure-response, quantitative system pharmacology (QSP), comparator modeling and other model-based analyses

• Maintaining a comprehensive understanding of global regulatory expectations for biologics as well as small molecules, authoring M&S reports for regulatory submissions

• Mentoring and/or supervising junior colleagues to perform the above duties and to develop the above capabilities

Principal Scientists in the Pharmacometrics group within QP2 are skilled pharmacometricians, with a strong, integrated understanding of the strategic elements of drug discovery and development, and lead the combined efforts of QP2 and the wider PPDM Department. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. In addition to the responsibilities described above, Principal Scientists demonstrate outstanding leadership and communication skills. They collaborate within QP2 and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams.

Education Minimum Requirements:

• Ph.D. or equivalent degree with ≥ 7 years of experience OR a PharmD or equivalent degree with ≥ 9 years of experience OR MS or equivalent degree with ≥ 11 years of experience , where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia

Required Experience and Skills:

• Educational background in pharmacometrics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field

• Experience in performing PK and PK/PD modeling for biologics and protein therapeutics

• Proficiency in NONMEM, R, Matlab, Monolix or other similar programing language

Preferred Experience and Skills:

• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry.

• Broad understanding of range of therapeutic modalities including more complex modalities such as multi-specifics, RNA therapeutics and fusion proteins/ADCs

• Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.

• Scientific understanding of biopharmaceutical and ADME properties

• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.

• Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Requisition ID:R123797