Merck
Principal Scientist, Drug Metabolism and Pharmacokinetics
Merck, Lansdale, Pennsylvania, United States
Principal Scientist, Drug Metabolism and Pharmacokinetics
Location: Lansdale, PA
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 providing an integrated understanding of DMPK properties, PK/PD, and DDI risk of novel therapeutics. The role collaborates with cross-functional teams to design and interpret in silico, in vitro, and in vivo analyses to support discovery and clinical development across modalities. They will assess DDI risk using static mechanistic and/or PBPK models and guide clinical development teams on DDI strategy. They will author source reports for regulatory filings and evaluate program risks to support efficient progression.
Responsibilities
Work within cross-functional teams to contribute to discovery and clinical development of therapeutics across modalities.
Guide design and interpretation of in silico, in vitro, and in vivo analyses to support DMPK-driven discovery and development.
Assess DDI risk using static mechanistic and/or PBPK models and guide DDI strategy for clinical programs.
Author source reports and regulatory submission documents (e.g., regulatory filings).
Independently evaluate program risks and implement strategies to address liabilities to ensure efficient progression and decision making.
Collaborate effectively in a fast-paced environment and demonstrate strong communication skills; experience with both small molecules and biologics is desired.
Qualifications Education Minimum: PhD or Master’s degree in Pharmaceutical Sciences, Pharmacology, Pharmacokinetics, Pharmacodynamics, Chemistry, Biomedical Engineering, Biochemistry, Toxicology, Biology, or related STEM field.
Required Experience And Skills
Master’s degree with 10+ years or PhD with 7+ years in industry/applied drug discovery/development, with focus on therapeutics across modalities (small molecules, antibodies, drug conjugates).
Experience integrating preclinical DMPK and pharmacology to enable translational modeling and simulation for dose selection and PK/PD/safety study design.
Ability to assess factors influencing PK/PD of novel therapeutics and communicate analyses to interdisciplinary teams and management.
Experience authoring documents for IB, IND, WMA filings, and regulatory inquiries.
Proven collaboration on multi-disciplinary discovery and development teams.
Strong leadership, interpersonal, communication, problem solving, and collaboration skills with ability to meet deadlines.
Preferred Experience And Skills
Strong publication track record.
Experience evaluating third-party assets for the DMPK function.
Experience with Phoenix and PBPK modeling software (e.g., SimCYP).
Experience mentoring or supervising junior staff.
Equal Employment Opportunity
statements and legal notices are available in the original posting. We are an equal opportunity employer and do not discriminate on the basis of race, color, religion, sex, etc. For full details, see the posting.
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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 providing an integrated understanding of DMPK properties, PK/PD, and DDI risk of novel therapeutics. The role collaborates with cross-functional teams to design and interpret in silico, in vitro, and in vivo analyses to support discovery and clinical development across modalities. They will assess DDI risk using static mechanistic and/or PBPK models and guide clinical development teams on DDI strategy. They will author source reports for regulatory filings and evaluate program risks to support efficient progression.
Responsibilities
Work within cross-functional teams to contribute to discovery and clinical development of therapeutics across modalities.
Guide design and interpretation of in silico, in vitro, and in vivo analyses to support DMPK-driven discovery and development.
Assess DDI risk using static mechanistic and/or PBPK models and guide DDI strategy for clinical programs.
Author source reports and regulatory submission documents (e.g., regulatory filings).
Independently evaluate program risks and implement strategies to address liabilities to ensure efficient progression and decision making.
Collaborate effectively in a fast-paced environment and demonstrate strong communication skills; experience with both small molecules and biologics is desired.
Qualifications Education Minimum: PhD or Master’s degree in Pharmaceutical Sciences, Pharmacology, Pharmacokinetics, Pharmacodynamics, Chemistry, Biomedical Engineering, Biochemistry, Toxicology, Biology, or related STEM field.
Required Experience And Skills
Master’s degree with 10+ years or PhD with 7+ years in industry/applied drug discovery/development, with focus on therapeutics across modalities (small molecules, antibodies, drug conjugates).
Experience integrating preclinical DMPK and pharmacology to enable translational modeling and simulation for dose selection and PK/PD/safety study design.
Ability to assess factors influencing PK/PD of novel therapeutics and communicate analyses to interdisciplinary teams and management.
Experience authoring documents for IB, IND, WMA filings, and regulatory inquiries.
Proven collaboration on multi-disciplinary discovery and development teams.
Strong leadership, interpersonal, communication, problem solving, and collaboration skills with ability to meet deadlines.
Preferred Experience And Skills
Strong publication track record.
Experience evaluating third-party assets for the DMPK function.
Experience with Phoenix and PBPK modeling software (e.g., SimCYP).
Experience mentoring or supervising junior staff.
Equal Employment Opportunity
statements and legal notices are available in the original posting. We are an equal opportunity employer and do not discriminate on the basis of race, color, religion, sex, etc. For full details, see the posting.
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