Director, Disease Biology (Cell Biology/Small Molecule)

We are seeking an experienced drug development scientist and dynamic leader.  Reporting to the VP, Disease Biology & Translational Science, this individual will be responsible for helping to establish and expand the company’s capabilities for preclinical in vitro and clinical ex vivo disease pathobiology establishing in vitro/ex vivo models to interrogate complex disease models to rank and screen our therapeutic candidates and establish the drug’s mechanism of action for multiple indications.  The Director will lead cell based therapeutic characterization and development efforts defining the compounds mechanism of action and efficacy in complex in vitro models of disease.  They will lead from the bench managing internal scientists as well as external CROs to execute strategies and be responsible for the development and conduct of in vitro, and/or ex vivo studies to support and advance Septerna’s drug discovery pipeline. They will work both independently and collaboratively as part of a matrixed inter-disciplinary team to establish the therapeutic mechanism of action of Septerna’s novel and differentiated drug candidates.  The successful candidate will be responsible for writing and reviewing reports as well as regulatory documents.  They will establish pharmacodynamic and efficacy relationships as appropriate to determine the potential clinical impact of Septerna drugs.  The successful candidate will serve as the Disease Biology lead on cross-functional research and development teams and have opportunities to lead programs from discovery through early development.  They will have the opportunity to demonstrate their scientific leadership within the R&D organization, contributing biological, disease area, and clinical insights to projects as well as ideas for new therapeutic programs.

 

The position is based in South San Francisco, CA. Title and compensation commensurate with experience.

 

• 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 mechanism of action for leads drug.
•  Serve as Disease Biology lead on multiple project teams, conduct and trouble-shoot experiments, analyze and interpret data and work cross functionally with colleagues to identify and mitigate risks and effectively advance therapeutic programs
• Help build complex in vitro and ex vivo research and development capabilities
• Author and review protocols, study reports, and regulatory documents to enable IND and other regulatory filings
• Follow all company policies/practices, and maintain accurate records and notebooks

• PhD Endocrinology, Physiology, Diabetes/Obesity, Immunology / Inflammation, or Metabolic Disease, or related biological science (MSc/BSs with relevant years of experience)
• At least 12 years direct hands-on experience in therapeutic development leveraging indication specific functional disease models in biotechnology and pharmaceutical industries (MSc with at least 15 years, BSc with at least 20years)
• Experience with cell-based assays, ELISA, MSD, qPCR, RNA-seq, microscopy, histology/pathology (e.g. IF/IHC/ISH), and/or flowcytometry
• Ability to be hands on and working in the lab, manage scientists, write protocols, execute studies leveraging Septerna in house capabilities or working with CROs
• Direct experimental experience with complex disease biology of diabetes, obesity or other metabolic disease
• Demonstrated expertise in building PK/PD and efficacy relationships with complex 2D/3D functional cell-based and tissue-based assays
• Leverage complex data sets to characterize therapeutic leads and establish a drug’s therapeutic mechanisms of action
• Experience working on/leading project teams with functional responsibility to propose strategy, analyze, interpret, and present complex data to inform decisions
• Ability to collaborate in 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/or regulatory documents including IBs, IND filings, CSRs, and/or NDAs
• Outstanding communication skills with demonstrated ability to make effective presentations in a broad range of settings
• Detail-oriented and organized, with strong interpersonal skills for clear and effective communication

• Experience with therapeutics programs which have yielded drugs entering clinical development in one or more of the following therapeutic areas:  endocrinology, diabetes / obesity, immunology / inflammation, or metabolic disease
• Experience with microscopy, confocal imaging, or similar a plus
• Experience working as a subject matter expert with complex cell-based 2D/3D culture systems or ex vivo tissue models or patient derived samples a plus
• Ability to generate, analyze and interpret multi-omic data sets
• Establish workflows, use Jupyter notebook or other platform to perform bioinformatics analysis and interpret and visualize complex data sets a plus
• Previous work leading a program in therapeutic discovery/development
• Strong statistical analysis skills and an ability to articulate findings and make recommendations from complex study results
• Experience mentoring scientists, leading cross-functional project teams, and a track record of successful management of external teams 

The anticipated salary range for candidates who will work in South San Francisco, CA is $220,000 - $240,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.