Principal Scientist, Pharmacokinetics

Requirements

• 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:
• Preferred Skills:
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Benefits

Additional Information

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.

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