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Associate Director-Diabetes

3 months ago

san francisco, United States BioPhase Full time

Associate Director-Diabetes & Obesity Biology


Key Responsibilities:

  • Serve as the Diabetes & Obesity Biology lead on multiple project teams; conduct and troubleshoot experiments, analyze and interpret data, and work cross-functionally with colleagues to identify and mitigate risks and effectively advance therapeutic programs.
  • Design and execute in vitro and ex vivo studies to advance therapeutic programs.
  • Generate, analyze, and interpret complex data to establish functional PK/PD and efficacy relationships and elucidate therapeutic mechanisms of action for lead drugs.
  • Develop and enhance complex in vitro and ex vivo research and development capabilities.
  • Author and review protocols, study reports, and regulatory documents to support IND and other regulatory filings.
  • Adhere to all company policies and practices, maintaining accurate records and notebooks.


Experience:

  • PhD in Immunology/Inflammation, Metabolic Disease, Physiology, Diabetes/Obesity, or a related biological science (MSc with relevant years of experience).
  • At least 7 years of direct hands-on experience in therapeutic development using indication-specific functional disease models in the biotechnology and pharmaceutical industries (MSc with at least 10 years).
  • Experience with therapeutic programs that have yielded drugs entering clinical development in endocrinology, diabetes/obesity, immunology/inflammation, or metabolic disease.
  • Proficiency with cell-based assays, ELISA, MSD, qPCR, RNA-seq, microscopy, histology/pathology (e.g., IF/IHC/ISH), and/or flow cytometry.
  • Ability to work hands-on in the lab, manage scientists, write protocols, and execute studies using in-house capabilities or in collaboration with CROs.
  • Direct experimental experience with the complex disease biology of diabetes, obesity, or other metabolic diseases.
  • Expertise in building PK/PD and efficacy relationships with complex 2D/3D functional cell-based and tissue-based assays.
  • Experience leveraging complex data sets to characterize therapeutic leads and establish therapeutic mechanisms of action.
  • Experience leading project teams with functional responsibility to propose strategies, analyze, interpret, and present complex data to inform decisions.
  • Proficiency in collaborating on writing protocols, reports, and regulatory documents.
  • Experience working with vendors and CROs to execute studies, analyze data, and generate reports in a timely manner.
  • Experience authoring study protocols, reports, and regulatory documents including IBs, IND filings, CSRs, and NDAs.
  • Outstanding communication skills with the ability to make effective presentations in various settings.
  • Detail-oriented and organized, with strong interpersonal skills for clear and effective communication.
  • Experience with microscopy, confocal imaging, or similar techniques is a plus.
  • Experience as a subject matter expert with complex cell-based 2D/3D culture systems, ex vivo tissue models, or patient-derived samples is a plus.
  • Ability to generate, analyze, and interpret multi-omic data sets.
  • Experience establishing workflows, using platforms like Jupyter Notebook for bioinformatics analysis, and interpreting and visualizing complex data sets is a plus.
  • Previous experience leading a program in therapeutic discovery/development.
  • Strong statistical analysis skills with the ability to articulate findings and make recommendations based on complex study results.
  • Experience mentoring scientists, leading cross-functional project teams, and successfully managing external teams.