Principal Scientist, Pharmacokinetics

Principal Scientist Drug Metabolism And Pharmacokinetics

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.

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:

The salary range for this role is $ - $. 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

You can apply for this role through  (or via the Workday Jobs Hub if you are a current employee). The Final date to receive applications for this position is stated on this posting.

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
Yes

Travel Requirements: 10%

Flexible Work Arrangements:
Hybrid

Requisition : R405141