Senior Research Scientist/Lead Research Scientist

1 week ago

San Diego, California, United States BioPhase Full time
Job Summary

At BioPhase, we are seeking a highly skilled Senior Scientist/Principal Scientist to lead our Metabolite Profiling efforts. This role will oversee the identification and characterization of metabolites, conduct enzymology studies, and drive innovation in our medicinal chemistry team.

Key Responsibilities
  • Metabolite Profiling: Oversee the identification and characterization of metabolites, and conduct enzymology studies to understand their impact on drug development.
  • Scientific Leadership: Provide scientific and strategic input to guide medicinal chemists in optimizing chemical series and solving complex problems.
  • Cross-Functional Collaboration: Work closely with team members to ensure innovative solutions and successful project outcomes.
  • Study Design and Management: Plan and execute in vitro soft-spot and tox species selection MetID studies and definitive in vivo MetID studies.
  • Experimental Work: Perform laboratory experiments and manage biotransformation studies conducted at Contract Research Organizations (CROs).
  • Data Analysis and Presentation: Interpret mass spectra, prepare data summaries, and present findings to project teams and management.
  • Regulatory Documentation: Author and support regulatory reports and documents to facilitate clinical development.
Requirements
  • Education and Experience: PhD in Organic Chemistry, Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline with 7+ years of industry experience; alternatively, MS/BS with 12+ years of relevant experience.
  • Expertise: Extensive knowledge in drug metabolism, in vitro enzyme kinetics, ADME assays, and LC/MS bioanalytical methodologies.
  • Biotransformation Studies: Proven experience in designing, executing, and reviewing biotransformation studies.
  • Regulatory Knowledge: Understanding regulatory guidance related to biotransformation, including MIST, with experience in preparing biotransformation documents for regulatory submissions is considered a plus.
Core Competencies
  • Communication Skills: Exceptional written and verbal technical communication abilities.
  • Leadership and Influence: Proven ability to lead, guide, and influence teams in decision-making processes.
  • Collaboration: Strong collaborative skills with the ability to build and maintain relationships across internal scientific functions and the broader scientific community.
  • Autonomy and Teamwork: Capability to work independently and collaboratively within a multidisciplinary team setting.
  • Data-Driven Analysis: Passion for data-driven analysis with a solid understanding of business-of-science thinking.
  • Adaptability: Ability to excel in a fast-paced, highly matrixed environment.
  • Technical Expertise: Deep knowledge of DMPK, biotransformation, enzymology, and DDI prediction strategies.
  • Track Record: Demonstrated success in leading studies that support IND filings and contribute to drug discovery.
  • CRO Management: Proficiency in managing CROs and a strong grasp of relevant regulatory guidance.

The ideal candidate will have strong expertise in mass spectrometry, experience with regulatory submissions, and a proven track record of working effectively in a team environment.

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