Senior Scientist, DMPK, PK Modeling

Reporting to the VP, Bioanalytical, Biomarkers and DMPK the Senior Scientist will be a highly motivated scientist who will contribute to the preclinical development to support the PepGen pipeline. In this hands-on laboratory position, the successful candidate will be responsible for ensuring the selection and utilization of in vitro and or in vivo methods and models to evaluate absorption, distribution, metabolism, excretion (ADME), and pharmacokinetic (PK). This scientist will closely coordinate activities with clinical, translational and discovery research.

This is a lab based role and requires strong PK modeling experience, ideally with WiNnonlin.

Responsibilities

• Ensure selection and utilization of appropriate in vitro and or in vivo methods and models to evaluate absorption, distribution, metabolism, excretion (ADME), and pharmacokinetic (PK)- related to oligonucleotide therapies
• Responsible for the analysis, interpretation, integration, and reporting of preclinical DMPK data generated both internally and with external vendors
• Build and develop quantitative tools to translate PK/PD relationship from preclinical to clinical using modeling and simulation for oligo therapeutics
• Participate in the management of CROs in the conduct of in vitro/in vivo ADME studies
• Prepare strategic and scientifically sophisticated ADME strategies that meet regulatory requirements and program goals
• Author high-quality Regulatory documents including INDs and CTAs filings. Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management, and other departments

Qualifications

• Degree in Pharmaceutical Sciences, Biochemistry, Chemistry, or a related field, including an MS degree with at least 8+ years of industry experience, or a Ph.D. degree with at least 6+ years of industry experience
• Expert knowledge of PK/pharmacometrics tools (e.g., NONMEM, Phoenix WinNonlin/NLME)
• In-depth understanding in oligonucleotide bioanalysis, including LC-MS/MS, HRMS, and other platforms
• Expertise in PK data analysis and PK/PD modeling and proficiency with Phoenix WinNonlin PK analysis software, or equivalent
• Self-motivation, ability to work independently and excellent organization skills that enable multitasking and working within timelines is required
• Ability to adapt and exercise flexibility for changing platform needs, workflows and projects
• Excellent oral and written communication skills and an ability to interact and conduct strategic planning with colleagues in other scientific disciplines
• In-depth knowledge of the overall drug discovery process and demonstrated ability to successfully direct efforts on multiple projects simultaneously

About PepGen

We are a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide range of indications and are rapidly growing our team at our U.S. headquarters in Boston, Massachusetts.

PepGen is proud to be an equal opportunity workplace and is an affirmative action employer.

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