Merck
Principal Scientist, Drug Metabolism and Pharmacokinetics
Merck, West Point, Nebraska, United States, 68788
Overview
The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function of our Research & Development Division in West Point, Pennsylvania, is seeking a dynamic and collaborative scientist for the Drug Metabolism and Pharmacokinetics (DMPK) group. The Principal Scientist will contribute to multi-disciplinary drug development and discovery efforts by providing an integrated understanding of DMPK properties, pharmacokinetics/pharmacodynamics (PK/PD), and drug interaction (DDI) risk of novel therapeutics. The key responsibilities involve working within teams of cross-functional scientists to support discovery and clinical development of therapeutics across modalities. The Principal Scientist will guide the design and interpretation of in silico, in vitro, and in vivo analyses to support discovery with the desired DMPK profile. They will assess DDI risk using static mechanistic and/or physiologically based pharmacokinetic (PBPK) models and guide clinical development teams on DDI strategy. They will author source reports and documents in support of regulatory filings. They will independently evaluate and predict program risks and implement strategies to address liabilities to ensure efficient program progression and decision making. The ideal candidate must work collaboratively in a fast-paced environment, drive scientific development and innovation, and have excellent interpersonal and communication skills. Experience supporting both small molecule and biologics programs is desired. Responsibilities
Collaborate in cross-functional teams to advance discovery and clinical development of therapeutics across modalities. Design and interpret in silico, in vitro, and in vivo DMPK analyses; ensure the therapeutic DMPK profile supports program goals. Assess DDI risk using static and PBPK models and advise on DDI strategies for clinical development. Author source reports and regulatory documentation (e.g., IB, IND) in support of filings. Proactively evaluate program risks and implement mitigation strategies to enable efficient progression and decision making. Qualifications
Education Minimum Requirement: PhD or Master’s degree in Pharmaceutical Sciences, Pharmacology, Pharmacokinetics, Pharmacodynamics, Chemistry, Biomedical Engineering, Biochemistry, Toxicology, Biology, or relevant STEM fields. Required Experience and Skills: Master’s degree with 10+ years relevant experience or PhD with 7+ years in industry/applied drug discovery/development, with focus on therapeutics across modalities (including small molecules, antibodies, and drug conjugates). Experience integrating preclinical DMPK and pharmacology to enable translational modeling and simulation for dose selection and PK/PD design and safety assessment in preclinical and clinical studies. Experience assessing factors affecting PK/PD of novel therapeutics and communicating analyses to interdisciplinary teams and management. Experience authoring documents in support of regulatory filings (IB, IND, responses to inquiries). Demonstrated ability to collaborate on multi-disciplinary discovery and development teams. Strong leadership, interpersonal, communication, problem solving, and collaboration skills with the ability to meet firm deadlines. Preferred Experience and Skills: Strong publication track record. Experience evaluating third-party assets for DMPK function. Experience building models and analyses using Phoenix and PBPK tools (e.g., SimCYP). Experience mentoring or supervising junior staff. Equal Employment Opportunity and Additional Information
We are an Equal Employment Opportunity Employer providing equal opportunities to all employees and applicants and prohibiting discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, see the following resources: EEOC Know Your Rights and GINA Supplement. We value diversity and inclusion and encourage candidates from all backgrounds to apply. The company supports hybrid work models where applicable and provides a comprehensive benefits package including medical, dental, vision, retirement, holidays, vacation, and sick leave. Salary range information is provided in the posting and is determined by factors including education, experience, location, and business needs. Application information: You can apply through the company careers site. The posting has an end date indicated in the job description. Additional Details
U.S. Hybrid Work Model policies apply where appropriate; this does not apply to field-based, facility-based, manufacturing-based, or remote-only roles unless specified. Travel requirements are up to 10%. Visa sponsorship is available for this role where applicable.
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The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function of our Research & Development Division in West Point, Pennsylvania, is seeking a dynamic and collaborative scientist for the Drug Metabolism and Pharmacokinetics (DMPK) group. The Principal Scientist will contribute to multi-disciplinary drug development and discovery efforts by providing an integrated understanding of DMPK properties, pharmacokinetics/pharmacodynamics (PK/PD), and drug interaction (DDI) risk of novel therapeutics. The key responsibilities involve working within teams of cross-functional scientists to support discovery and clinical development of therapeutics across modalities. The Principal Scientist will guide the design and interpretation of in silico, in vitro, and in vivo analyses to support discovery with the desired DMPK profile. They will assess DDI risk using static mechanistic and/or physiologically based pharmacokinetic (PBPK) models and guide clinical development teams on DDI strategy. They will author source reports and documents in support of regulatory filings. They will independently evaluate and predict program risks and implement strategies to address liabilities to ensure efficient program progression and decision making. The ideal candidate must work collaboratively in a fast-paced environment, drive scientific development and innovation, and have excellent interpersonal and communication skills. Experience supporting both small molecule and biologics programs is desired. Responsibilities
Collaborate in cross-functional teams to advance discovery and clinical development of therapeutics across modalities. Design and interpret in silico, in vitro, and in vivo DMPK analyses; ensure the therapeutic DMPK profile supports program goals. Assess DDI risk using static and PBPK models and advise on DDI strategies for clinical development. Author source reports and regulatory documentation (e.g., IB, IND) in support of filings. Proactively evaluate program risks and implement mitigation strategies to enable efficient progression and decision making. Qualifications
Education Minimum Requirement: PhD or Master’s degree in Pharmaceutical Sciences, Pharmacology, Pharmacokinetics, Pharmacodynamics, Chemistry, Biomedical Engineering, Biochemistry, Toxicology, Biology, or relevant STEM fields. Required Experience and Skills: Master’s degree with 10+ years relevant experience or PhD with 7+ years in industry/applied drug discovery/development, with focus on therapeutics across modalities (including small molecules, antibodies, and drug conjugates). Experience integrating preclinical DMPK and pharmacology to enable translational modeling and simulation for dose selection and PK/PD design and safety assessment in preclinical and clinical studies. Experience assessing factors affecting PK/PD of novel therapeutics and communicating analyses to interdisciplinary teams and management. Experience authoring documents in support of regulatory filings (IB, IND, responses to inquiries). Demonstrated ability to collaborate on multi-disciplinary discovery and development teams. Strong leadership, interpersonal, communication, problem solving, and collaboration skills with the ability to meet firm deadlines. Preferred Experience and Skills: Strong publication track record. Experience evaluating third-party assets for DMPK function. Experience building models and analyses using Phoenix and PBPK tools (e.g., SimCYP). Experience mentoring or supervising junior staff. Equal Employment Opportunity and Additional Information
We are an Equal Employment Opportunity Employer providing equal opportunities to all employees and applicants and prohibiting discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, see the following resources: EEOC Know Your Rights and GINA Supplement. We value diversity and inclusion and encourage candidates from all backgrounds to apply. The company supports hybrid work models where applicable and provides a comprehensive benefits package including medical, dental, vision, retirement, holidays, vacation, and sick leave. Salary range information is provided in the posting and is determined by factors including education, experience, location, and business needs. Application information: You can apply through the company careers site. The posting has an end date indicated in the job description. Additional Details
U.S. Hybrid Work Model policies apply where appropriate; this does not apply to field-based, facility-based, manufacturing-based, or remote-only roles unless specified. Travel requirements are up to 10%. Visa sponsorship is available for this role where applicable.
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