About The Position
The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function of our Research & Development Division in West Point, Pennsylvania, is seeking 2 dynamic and collaborative scientists for the Drug Metabolism and Pharmacokinetics (DMPK) group. The Associate Principal Scientist will be a key contributor to multi-disciplinary drug discovery and development 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 working on teams of highly collaborative, cross-functional scientists to discover and develop therapeutics across various modalities. The Associate Principal Scientist will design and interpret 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 (e.g. antibodies and drug conjugates) programs is desired.
Requirements
- Bachelor’s, Master’s, or PhD degree in Pharmaceutical Sciences, Pharmacology, Chemistry, Biomedical Engineering, Biochemistry, Biology, Biophysics, Biostatistics, or relevant STEM fields.
- Bachelor’s with 10+, Master’s degree with 8+ or PhD with 5 + 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).
- Strong leadership, interpersonal, communication, problem solving, and collaboration skills, while delivering results on firm deadlines.
- Experienced 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.
Nice To Haves
- 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.
Responsibilities
- Working on teams of highly collaborative, cross-functional scientists to discover and develop therapeutics across various modalities.
- Design and interpret in silico, in vitro, and in vivo analyses to support the discovery of therapeutics with the desired DMPK profile.
- Assess DDI risk using static mechanistic and/or physiologically based pharmacokinetic (PBPK) models and guide clinical development teams on DDI strategy.
- Author source reports and documents in support of regulatory filings.
- Independently evaluate and predict potential program risks, while implementing appropriate strategies to address liabilities to ensure efficient program progression and decision making.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
