Senior Scientist, Drug Metabolism & Pharmacokinetics; DMPK

Position: Senior Scientist, Drug Metabolism & Pharmacokinetics (DMPK)
Company Overview:

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities.

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Position Overview

We are seeking a motivated and skilled Senior Scientist to join the Nonclinical Development group, contributing to the DMPK function in support of exploratory and IND-enabling programs across Prime Medicine's pipeline. Reporting to the Associate Director, DMPK/Bioanalytical Sciences, this individual will independently analyze and interpret datasets from in vivo studies, contribute to nonclinical regulatory documents, and work cross-functionally with pharmacology, translational biology and external CROs, to ensure high-quality DMPK data packages are delivered to support program timelines.

The ideal candidate has a strong foundation in in vivo pharmacokinetics for RNA therapeutics and/or LNP-based delivery systems, thrives in a fast-paced and matrixed organization, and possesses the flexibility and positive attitude needed to make meaningful contributions to the Nonclinical Development team.

Primary Responsibilities

* Analyze and interpret PK study data from exploratory and IND-enabling in vivo

* Perform non-compartmental analysis (NCA) using Phoenix Win Nonlin to derive key PK parameters (Cmax, AUC, T½, Vd, CL).

* Leverage expertise in DMPK to provide recommendations for in vivo study designs in collaboration with pharmacology and key stakeholders.

* Perform bioanalytical assay development (30%) and collaborate with bioanalytical scientists to trouble-shoot challenges during method development to ensure quantitative methods for key analytes (LNP lipid components, mRNA, pegRNA, PD biomarkers) meet regulatory expectations and data quality standards..

* Contribute to nonclinical regulatory documents including pharmacokinetics summaries and nonclinical study reports under the guidance of senior stakeholders in Nonclinical Development.

* Maintain thorough records in the electronic laboratory notebook (ELN); prepare clear data summaries, presentations, and technical memos for program team and governance meetings.

Qualifications

Minimum Qualifications

* D. in pharmacokinetics, pharmaceutical sciences, pharmacology, biochemistry, or a related discipline.

* 6+ years of cumulative experience. Industry experience (biotech or pharmaceutical) with direct responsibility for in vivo DMPK study design, execution, and interpretation is required; postdoctoral training in a DMPK or translational pharmacology setting is strongly preferred

* Demonstrated experience with in vivo PK studies in preclinical models and proficiency in NCA using Phoenix Win Nonlin or equivalent software.

* Familiarity with regulatory expectations for nonclinical DMPK assessments and bioanalytical assay development.

* Demonstrated ability to coordinate with external CROs, including scientific guidance, protocol development, and data review..

* Strong written and verbal communication skills; ability to present complex DMPK data clearly to multidisciplinary audiences.

* Highly self-motivated, collaborative, and organized, with the ability to manage multiple priorities independently in a fast-paced matrix environment.

Preferred Qualifications

* Familiarity with PK/PD modeling concepts; experience with Phoenix Win Nonlin modeling modules a plus.

* Experience with LNP-based delivery systems and/or RNA therapeutics (mRNA, siRNA, ASO, sgRNA or related modalities).

* Experience with exploratory DMPK studies, evaluating new delivery vehicles and evaluation of biodistribution using in vivo

* Familiarity with bioanalytical platforms supporting DMPK studies, including LC-MS/MS, RT-qPCR/ddPCR, ELISA/MSD.

* Ability and excitement to contribute to the development and success of the Nonclinical Development team.

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience,…