Associate Director-Diabetes
1 month ago
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.
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