Ophirex, Inc. · 18 hours ago

Senior Principal Scientist

United States

Full-time

Remote

Senior Level, Lead/Staff

5+ years exp

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BiotechnologyMedical

Hiring Manager

Ellen Douglas

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Responsibilities

Design and oversee nonclinical ADME, PK and pharmacology studies; interpret data from nonclinical studies and clinical trials to provide insights on PK and drug efficacy; Clinical Pharmacology experience a plus

Execute pharmacology strategies for small molecule drug development

Work with CRO(s) and consultant(s) to develop and execute modeling and simulation strategies

Provide PK and PD expertise to cross-functional teams

Manage nonclinical studies performed by CROs for ADME, PK, toxicology, pathology, pharmacology (e.g.oversee study completion, coordinate timing, ensure materials are provided to CRO, coordinates review of data and reports)

Coordinate contracts and protocols with CROs and internal stakeholders

Provide organizational skills and management to the nonclinical development program

Track project progress, proactively identifying and addressing risks, delays, or resource constraints to ensure timely project completion

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Drug MetabolismPharmacokinetics (PK)Pharmacodynamics (PD)ModelingSimulationPharmaceutical DevelopmentRegulatory SubmissionsData AnalysisClinical PharmacologyPharmDToxicologyPathology

Required

PhD or PharmD in Pharmacy, Pharmacology, Toxicology, Pathology, or similar with prior experience with regulatory submissions

5-7 years’ experience in pharmaceutical development operating in ADME, clinical pharmacology, preclinical and/or translational science, with an ability to work remotely

Experience in nonclinical and clinical PK and PD, with an understanding of modeling and simulation techniques (e.g., NONMEM, Phoenix, or similar software); direct experience with software a plus

An understanding of Ophirex’s Mission and desire to work in a Pharmaceutical Public Benefit Corporation

Ability to think strategically, balance short-term and long-term goals, manage complex projects, and maintain flexibility to adapt to situations

Strong skills in writing, data analysis, and technical review of data and documents mandatory

Excellent problem solving, critical thinking, and communication skills with the ability to understand, communicate, and present technical and complicated solutions in a clear and simple manner to stakeholders

Proven ability to organize multifaceted programs, and complete high-quality studies, manage CROs, processes, and reports supporting regulatory submissions