Principal Scientist, Pharmacokinetics
PharmaBiotechRegulatory AffairsQuality Assuranceemacroraveinformaws
Job description
Job Description 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 clinical development and discovery 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 development and discovery of therapeutics with the desired DMPK profile. They will assess program risks including DDI, metabolism and translation to guide clinical development teams. They will author source reports and regulatory documents in support of filings. They will independently evaluate and predict potential program risks, while implementing appropriate strategies to address liabilities and 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 (e.g. antibodies and drug conjugates) programs is desired. Qualifications Education Minimum Requirement: PhD or Master’s degree in Pharmaceutical Sciences, Pharmacology, Chemistry, Biomedical Engineering, Biochemistry, or relevant life sciences fields. Required Experience and Skills: Master’s degree with 12+ years relevant experience or PhD with 8 + years of industry experience in a relevant field with a focus on discovery and development of therapeutics of various modalities (including small molecules, antibodies, and drug conjugates). Demonstrated ability to support early to late stage clinical development programs as a DMPK representative including evaluating and mitigating risks, integrating emerging data into ongoing programs, and clearly communicating with a varied development team. Ability to drive DDI strategy for clinical programs, ensuring timely risk assessment and appropriate clinical plans are in place. Experience with authoring documents in support of IB, IND, WMA filings, and responses to regulatory inquiries. Experience working as a DMPK lead on discovery teams advancing therapeutics to clinical development across modalities (small molecule, peptides, biologics and conjugates). 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. Required Skills: ADME, Bioanalytical Method Development, Biopharmaceuticals, Biopharmaceutics, Business Interactions, Clinical Development, Clinical Judgment, Cross-Functional Teamwork, Detail-Oriented, Drug Development, Drug Interactions, Drug Metabolism, Immunoassays, Innovation, Life Science, Mentoring Staff, Pharmacodynamics, Pharmacokinetics, Pharmacology, PKPD Modeling Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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. 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 The salary range for this role is $173,200.00 - $272,600.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Job
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