Scientist/Toxicologist

The Opportunity: Scientist/Toxicologist

We are seeking a highly motivated Scientist/Toxicologist to lead investigative safety strategies for small molecule and emerging modalities and work in close collaboration with colleagues across our Research and Development organizations to enable the advancement of portfolio programs. The successful candidate will bring a strong investigative understanding of mechanism of toxicity and deliver bespoke predictive models of toxicity and nonclinical safety assessment strategies. Further, the ideal candidate will:

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  Function primarily as an investigative toxicologist to develop and deliver novel approach methods (NAMs) including predictive 2D and 3D models for nonclinical safety assessments.
  
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    Design, execute and deliver in vitro/ex vivo assays to detect and derisk toxicities for candidate drug molecules.
    
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    Assess new technologies to support/improve compound toxicity prediction & screening, and development of translational/safety biomarkers.
    
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    Design, analyze and oversee in vivo studies to better understand mechanisms of toxicity and help develop mitigation strategies of our pipeline.
    
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    Partner with internal and external collaborators and stakeholders related to integrated large-scale data analytics, computational and chemical mining efforts.
    

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  Function as a project toxicologist on drug discovery and development project teams and be a strong advocate for patient safety.
  
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    Design and oversee nonclinical toxicology programs to advance pipeline of small molecule cancer therapeutics by implementing target de-risking, screening, in vivo testing strategies, risk mitigation, and investigation of toxicities.
    
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  Effectively implement and oversee studies outsourced to CROs, in collaboration with study operations, pharmacology, DMPK and clinical pharmacology functions.
  
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  Analyze, interpret, and summarize nonclinical safety data, and present and contextualize meaningful findings with recommendations to internal project teams and leadership.
  
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  Ensure timely and accurate nonclinical study deliverables of projects to enable compound progression and decision-making, including drafting and reviewing of nonclinical sections of regulatory documents.
  

Required Skills, Experience and Education:

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  Ph.D. degree in Toxicology, Pharmacology, Immunology, Cancer biology or related discipline with 1-2 years of relevant biotech/pharma drug discovery/development experience in a team-facing role.
  
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  Strong scientific background and scientific aptitude, with excellent critical thinking and creative problem-solving skills.
  
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  Ability to work effectively, independently and collaboratively on cross-functional project teams; demonstrated ability to multitask, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.
  
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  Experience with advanced cell culture approaches with immortalized cell lines, primary cells, whole blood, PBMCs and iPSC cells.
  
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  Cell and molecular biology techniques including flow cytometry, Luminex/MSD, ELISA, and biomarker assay development and validation.
  
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  Proven expertise in 3D cell culture systems such as tumor spheroids, organoids, complex in vitro models and organ-on-a-chip models.
  
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  Expertise designing & delivering fit for purpose assays for understanding the mechanism of toxicity of agents including small molecule drugs, for biomarker development and application, and for derisking drug candidates.
  
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  Experience working in a matrixed team environment at a biotech/pharma company or CRO.
  
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  Excellent verbal, oral and written communication skills.
  
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  Strong interpersonal and organizational skills.
  
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  Thrives in a collaborative team setting and is driven by a desire to be innovative in a high energy, biotech company environment.
  

Preferred Skills:

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  Experience working with small molecules and targeted oncology therapeutics of all modalities.
  
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  Familiarity with GLPs and FDA/ICH guidance documents for nonclinical toxicology is desirable.