Distinguished Scientist, Pharmacokinetics

## Distinguished Scientist, Pharmacokinetics Apply:
Hybrid:
USA
- Pennsylvania
- West Point:
USA
- Massachusetts
- Boston (MA Parcel B Laboratory):
USA
- Pennsylvania
- Upper Gwynedd:
USA
- New Jersey
- Rahway:
USA
- California
- South San Francisco (Grand Ave):
Full time:
Posted Today:
End Date:
November 2, 2026 (23 days left to apply):
R421412
** Job Description
** The department of Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) is seeking a Distinguished Scientist to serve as Drug Metabolism and Pharmacokinetics (DMPK) submission expert. This leader will have broad responsibilities in support of our robust development pipeline to ensure consistent quality filings from FIH to marketing applications and through life-cycle management.

The Distinguished Scientist will contribute to the execution of PDMB portfolio support strategy and DMPK priorities across therapeutic areas and modalities. The successful candidate will ensure that submission packages as they pertain to nonclinical Pharmacokinetics (PK) are robust and aligned with program objectives. They will bring forward drug disposition properties in the context of benefit/risk and drug interaction potential in target populations within the parameters of regulatory guidelines.  

The Distinguished Scientist will be positioned to influence portfolio decisions, contribute to regulatory filings, labeling discussions and approvals. As a member of the DMPK Leadership team, the Distinguished Scientist will contribute to global scientific and portfolio strategy and talent development. They are expected to demonstrate exemplary ways of working, strong ethics, good negotiation skills and an enterprise mindset.  
** Key responsibilities**:

The Distinguished Scientist will assume strategic responsibilities that include but are not limited to:
* Monitor the progression of programs in late-stage development and post-marketing to ensure nonclinical packages in support of original marketing applications (OMA) and supplemental applications (sNDA) are robust, prepared timely, according to filing strategy and aligned with clinical safety and efficacy positions
* Represent PDMB in Label Approval Strategy Teams and in ad-hoc discussions/ teams where DMPK expertise is required, such as Clinical Safety/Risk Management, nonclinical safety mechanistic investigations as they pertain to regulatory filings, ICH guidance or label updates.
* Reviewing investigator brochures, clinical trial applications, IND, NDAs, regulatory responses and other legal/scientific documents to support global clinical trials and registration.
* Provide scientific and strategic oversight for development candidates across therapeutic areas through close collaboration with PDMB program representatives, subject-matter experts and management as well as key partners in other functional areas, including but not limited to Nonclinical Safety, Translational Medicine, Quantitative Pharmacology, Regulatory Affairs, Formulation and others to ensure alignment on regulatory strategy and input for mechanistic investigations.
* Actively contribute to discussions regarding Clinical Pharmacology strategy, including starting dose, dose escalation, timing, design and interpretation of Ph1 studies, such as drug interactions, especial populations and human ADME amongst other studies, leveraging nonclinical data generated by PDMB.
* Ensuring DMPK data and documentation practices maintain quality in pace with changes in regulatory expectations across countries/regions.
* Leading internal and cross-departmental initiatives to improve policies, procedures, and/or strategic direction in line with company portfolio strategy and regulatory expectations.
* Responsible for overseeing and/or conducting critical due diligence…