Hispanic Alliance for Career Enhancement
Principal Scientist, Drug Metabolism and Pharmacokinetics
Hispanic Alliance for Career Enhancement, West Point, Pennsylvania, us, 19486
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 key responsibilities will be to work within teams of highly collaborative, cross-functional scientists to contribute to the discovery and clinical development of therapeutics across various modalities. The Principal Scientist 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. They will independently evaluate and predict potential program risks, while implementing appropriate strategies to address liabilities to ensure 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.
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 of industry/applied drug discovery/development experience in a relevant field with a focus on discovery and development of therapeutics of various modalities (including small molecules, antibodies, and drug conjugates).
Experience in integrating preclinical DMPK and pharmacology to enable translational modeling and simulation to support dose selection, design of PK/PD and safety assessment studies, and dose justifications for preclinical and clinical studies.
Experience in assessing the impact of various factors on the pharmacokinetics and pharmacodynamics of novel therapeutics and communicating analyses and recommendations to interdisciplinary teams and management.
Experience with authoring documents in support of IB, IND, WMA filings, and responses to regulatory inquiries.
Demonstrated track record as an effective collaborator on multi-disciplinary discovery and development teams.
Strong leadership, interpersonal, communication, problem solving, and collaboration skills, while delivering results on firm deadlines.
Preferred Experience and Skills:
Strong publication track record
Experience representing the DMPK function in the evaluation of third-party assets.
Experience building models and performing analyses using Phoenix and PBPK modeling software (e.g., SimCYP).
Experience mentoring or supervising junior staff.
Company and Compliance As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment 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 applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
Additional Details US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
U.S. Hybrid Work Model : Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, with Friday remote, unless business critical tasks require on-site presence.
Salary Range:
$169,700.00 - $267,200.00
Benefits:
We offer a comprehensive package of benefits including medical, dental, vision, retirement benefits (e.g., 401(k)), paid holidays, vacation, and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Application : You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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The key responsibilities will be to work within teams of highly collaborative, cross-functional scientists to contribute to the discovery and clinical development of therapeutics across various modalities. The Principal Scientist 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. They will independently evaluate and predict potential program risks, while implementing appropriate strategies to address liabilities to ensure 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.
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 of industry/applied drug discovery/development experience in a relevant field with a focus on discovery and development of therapeutics of various modalities (including small molecules, antibodies, and drug conjugates).
Experience in integrating preclinical DMPK and pharmacology to enable translational modeling and simulation to support dose selection, design of PK/PD and safety assessment studies, and dose justifications for preclinical and clinical studies.
Experience in assessing the impact of various factors on the pharmacokinetics and pharmacodynamics of novel therapeutics and communicating analyses and recommendations to interdisciplinary teams and management.
Experience with authoring documents in support of IB, IND, WMA filings, and responses to regulatory inquiries.
Demonstrated track record as an effective collaborator on multi-disciplinary discovery and development teams.
Strong leadership, interpersonal, communication, problem solving, and collaboration skills, while delivering results on firm deadlines.
Preferred Experience and Skills:
Strong publication track record
Experience representing the DMPK function in the evaluation of third-party assets.
Experience building models and performing analyses using Phoenix and PBPK modeling software (e.g., SimCYP).
Experience mentoring or supervising junior staff.
Company and Compliance As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment 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 applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
Additional Details US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
U.S. Hybrid Work Model : Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, with Friday remote, unless business critical tasks require on-site presence.
Salary Range:
$169,700.00 - $267,200.00
Benefits:
We offer a comprehensive package of benefits including medical, dental, vision, retirement benefits (e.g., 401(k)), paid holidays, vacation, and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Application : You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
#J-18808-Ljbffr