MSD
Principal Scientist, Drug Metabolism and Pharmacokinetics
MSD, 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 be a key contributor to multi-disciplinary drug development and discovery efforts providing an integrated understanding of DMPK properties, pharmacokinetics/pharmacodynamics (PK/PD), and drug interaction (DDI) risk of novel therapeutics. The Principal Scientist will work within teams of highly collaborative, cross-functional scientists to contribute to the discovery and clinical development of therapeutics across various modalities. They will guide the design and interpretation of in silico, in vitro, and in vivo analyses to support the discovery of therapeutics 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 and independently evaluate and predict potential program risks while implementing strategies to address liabilities for efficient program progression and decision making. The ideal candidate must be able to 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
Contribute to discovery and clinical development of therapeutics across various modalities within cross-functional teams. Guide design and interpretation of in silico, in vitro, and in vivo analyses to support DMPK-driven decision making. Assess DDI risk using static models and/or PBPK modeling and advise on DDI strategies in clinical development. Author source documents in support of regulatory filings and communicate program risks with mitigation strategies. Proactively evaluate program liabilities and implement strategies to ensure 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 of relevant industry experience or PhD with 7+ years of experience in drug discovery/development, with a focus on therapeutics of various modalities (including small molecules, antibodies, and drug conjugates). Experience integrating preclinical DMPK and pharmacology with translational modeling to support dose selection, PK/PD design and safety assessments for preclinical and clinical studies. Ability to assess factors affecting PK/PD of novel therapeutics and clearly communicate analyses and recommendations to interdisciplinary teams and management. Experience authoring documents in support of regulatory filings (IB, IND, WMA) and responses to inquiries. Proven collaboration on multi-disciplinary discovery and development teams. Strong leadership, communication, problem solving, and collaboration skills with a track record of delivering results on deadlines. Preferred Experience and Skills: Strong publication track record. Experience evaluating third-party assets within the DMPK function. Experience building models and performing analyses using Phoenix and PBPK tools (e.g., SimCYP). Experience mentoring or supervising junior staff. Additional Information
Equal Employment Opportunity: We provide equal opportunities to all employees and applicants and prohibit 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. EEO laws, visit: EEOC Know Your Rights and EEOC GINA Supplement. We value diverse experiences and perspectives and encourage colleagues to collaborate respectfully and tackle problems collectively. Learn about rights under California, Colorado, and other U.S. state acts. Other Information
U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions will work a Hybrid schedule with three days on-site per week (Mon-Thu) and one remote day (Fri), subject to site needs. This model may not apply to all roles. Salary range: $169,700.00 - $267,200.00. The range reflects good-faith estimates at posting time and may vary based on factors including education, experience, location, and business needs. Benefits include medical, dental, vision, retirement plans (401(k)), holidays, vacation, and sick days. More information at the compensation and benefits page. Application: You can apply at the company careers site or via the Workday Jobs Hub if you are a current employee. The posting end date is indicated on the job posting.
#J-18808-Ljbffr
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 be a key contributor to multi-disciplinary drug development and discovery efforts providing an integrated understanding of DMPK properties, pharmacokinetics/pharmacodynamics (PK/PD), and drug interaction (DDI) risk of novel therapeutics. The Principal Scientist will work within teams of highly collaborative, cross-functional scientists to contribute to the discovery and clinical development of therapeutics across various modalities. They will guide the design and interpretation of in silico, in vitro, and in vivo analyses to support the discovery of therapeutics 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 and independently evaluate and predict potential program risks while implementing strategies to address liabilities for efficient program progression and decision making. The ideal candidate must be able to 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
Contribute to discovery and clinical development of therapeutics across various modalities within cross-functional teams. Guide design and interpretation of in silico, in vitro, and in vivo analyses to support DMPK-driven decision making. Assess DDI risk using static models and/or PBPK modeling and advise on DDI strategies in clinical development. Author source documents in support of regulatory filings and communicate program risks with mitigation strategies. Proactively evaluate program liabilities and implement strategies to ensure 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 of relevant industry experience or PhD with 7+ years of experience in drug discovery/development, with a focus on therapeutics of various modalities (including small molecules, antibodies, and drug conjugates). Experience integrating preclinical DMPK and pharmacology with translational modeling to support dose selection, PK/PD design and safety assessments for preclinical and clinical studies. Ability to assess factors affecting PK/PD of novel therapeutics and clearly communicate analyses and recommendations to interdisciplinary teams and management. Experience authoring documents in support of regulatory filings (IB, IND, WMA) and responses to inquiries. Proven collaboration on multi-disciplinary discovery and development teams. Strong leadership, communication, problem solving, and collaboration skills with a track record of delivering results on deadlines. Preferred Experience and Skills: Strong publication track record. Experience evaluating third-party assets within the DMPK function. Experience building models and performing analyses using Phoenix and PBPK tools (e.g., SimCYP). Experience mentoring or supervising junior staff. Additional Information
Equal Employment Opportunity: We provide equal opportunities to all employees and applicants and prohibit 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. EEO laws, visit: EEOC Know Your Rights and EEOC GINA Supplement. We value diverse experiences and perspectives and encourage colleagues to collaborate respectfully and tackle problems collectively. Learn about rights under California, Colorado, and other U.S. state acts. Other Information
U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions will work a Hybrid schedule with three days on-site per week (Mon-Thu) and one remote day (Fri), subject to site needs. This model may not apply to all roles. Salary range: $169,700.00 - $267,200.00. The range reflects good-faith estimates at posting time and may vary based on factors including education, experience, location, and business needs. Benefits include medical, dental, vision, retirement plans (401(k)), holidays, vacation, and sick days. More information at the compensation and benefits page. Application: You can apply at the company careers site or via the Workday Jobs Hub if you are a current employee. The posting end date is indicated on the job posting.
#J-18808-Ljbffr