BioSpace · 5 hours ago

Principal Research Scientist I

Massachusetts, United States

Full-time

Remote

Senior Level, Lead/Staff

6+ years exp

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Comp. & Benefits

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Responsibilities

Serve as a QTAS representative on multidisciplinary project teams supporting the development of novel small molecules; collaborate with project team members (e.g., discovery, toxicology, clinical pharmacology) and groups within QTAS to generate relevant data guiding target validation, biomarker selection, and candidate selection

Develop and drive the QTAS and PK/PD strategy for small molecule discovery, preclinical, and clinical development of projects to support decisions and milestone transitions

Effectively communicate QTAS and PK/PD strategy and knowledge to project teams, functional leaders, and other key stakeholders to ensure alignment and influence decisions

Demonstrate thorough understanding of ADME sciences and PK/PD aspects necessary to optimize drug candidates

Coordinate and request ADME, PK and PK/PD studies in a timely manner and communicate protocols, timelines, needs and results back to team, ensuring optimized cycle times

Integrate ADME, PK, PK/PD data with discovery biology data and provide thought leadership to project teams as a functional representative

Prepare QTAS sections of regulatory submission documents (IND, IB, NDA); provide responses to regulatory questions and ensure generation of appropriate reports

Mentor junior project reps

Qualification

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BiochemistryDrug MetabolismPharmacokineticsPK analysisPhoenix/WinNonlinPK/PD modelingData analysisRegulatory submission documentsPublication recordNetworking skills

Required

PhD in Biochemistry, Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences, or related area with 6+ years of experience in the pharmaceutical or biotechnology industry, or MS with 12+ years, or BS with 14+ years of industry experience

Experience independently representing QTAS on small molecule project teams is required

Expertise in PK analysis and relevant data analysis software such as Phoenix/WinNonlin is required

Ability to quickly adapt in-house visualization tools for data interpretation and presentation

Strong understanding of Drug Metabolism, PK, PK/PD modeling, human PK and DDI prediction strategies

Demonstrated scientific leadership including generating original scientific investigative strategies and guiding those efforts to an effective and productive outcome

Recognized expert in his/her discipline

Demonstrated publication or patent record; lead/senior author contributions a plus

Ability to influence, negotiate and communicate effectively with both internal and external stakeholders; ability to work well in a collaborative fast-paced team environment

Highly motivated, self-driven and results-oriented with excellent communication and presentation skills; capable of working both as team player and project driver

High degree of flexibility in adapting to different projects and people; excellent networking and relationship-building (both internal and external) skills

Passion for data analysis, solving technical problems and applying new technologies to further scientific goals