Discovery / Research

Clinical Biomarker Sr. Scientist, Oncology Direct Hire MA

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Job ID: 15344 Direct Hire MA

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Global Biologics looking add a Clinical Biomarker Sr. Scientist to their Translational Medicine Oncology Research group here in Cambridge, MA!  This role will work on a global team and help lead the Translational Medicine strategy and execution for Oncology projects in Research and Development.  Will work cross-functionally as the Oncology Translational Medicine rep for both early and late stage projects and help implement clinical biomarkers into clinical trials and provide translational medicine solutions projects.  Other responsibilities include:

  • Identify patient population susceptible to respond to novel agents in Oncology, establish plan to validate hypothesis on selection biomarkers.
  • Define pharmacodynamic markers related the mechanism of action of the drug in clinical development.
  • Design preclinical and biomarker clinical studies to test novel hypothesis on drug MOA, identify immune and tumor related biomarkers.
  • Identify new indications and propose new drug combination based on evidenced tumor /immune MOA.
  • Expend discovery research through translational human biology studies (epidemiology in human clinical samples).
  • Create strategies to guide the development of a compound from discovery to development, to regulatory agencies, to business launch, and life cycle management.
  • Develop collaborative studies with external investigators from academic centers, hospitals or technological expert companies.
  • Identify and maintain close relationship with CROs in outsourcing biomarker analysis of clinical trial samples. Work closely with Trial Operation in setting up logistics, tracking sample, performing data analysis and data transfer for statistical analyses.
  • Responsible for authoring biomarker sections of clinical trial related documents including IB, IND, CSR, as well as regulatory submission.

Requirements:

  • PhD with post-doctoral experience or equivalent in biology, molecular biology, Pharmacology or related field with emphasis on cancer is required.
  • 3+ years’ experience in preclinical research and /or early clinical development with focus Biomarkers
  • Experience with immune-oncology therapies, tumor/ immune profiling
  • 5+ years of Translational research experience

Sr. Scientist, Neurodegenerative Diseases Direct Hire MA

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Job ID: 15311 Direct Hire MA

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Global Biologics company looking to add a Sr. Scientist to their Neurodegenerative Diseases research team!  This role will focus on conducting discovery research and target validation in neuron-glia signaling underlying myelination and neuroprotection.  Will study cellular and molecular mechanisms that underlie responses to oxidative, excitotoxic, inflammatory and ionic stressors in the context of diseases like MS and other neurodegenerative disorders.  The Sr. Scientist will also lead research projects and cross-functional teams from target discovery and validation to lead candidate identification as well as supporting Phase 1 and 2 studies.  Other responsibilities include: 

  • Establish in vitro cell-based models of neuron-glia interactions including myelinating cultures of mixed cortical neurons and-glia, cerebellar and cortical tissue explants, and develop, validate and optimize oligodendrocyte differentiation assays using rodent and human cells.
  • Conduct in vivo experimental work in animal models of MS, e.g. demyelination/remyelination and immune-driven models.
  • Conduct laboratory research on projects for the lab, MS Research group, and the Neuroscience Therapeutic Area.
  • Contribute to strategic and tactical selection of drug targets for MS.
  • Interact with cross-functional groups and Neuroscience research colleagues in the US and EU.
  • Collaborate productively and efficiently with scientific colleagues in various groups including Immunology and Inflammation, Chemistry, Biologics Research, DMPK, Preclinical Safety, Translational Sciences, among others, in the US and EU.
  • Prepare and communicate results at external meetings and in publications of high quality.
  • Establish and maintain a scientific network external to the company to continue to develop expertise in cutting edge science and technology to facilitate Neuroscience strategy.

Requirements:

  • Ph.D. in Neuroscience or related field and 3+ years of research experience in MS and/or neurodegenerative diseases.
  • Strong track record of publications in neuroscience, neuroimmunology, neurodegeneration and/or MS.
  • Understanding of neuronal and glial cell biology and pathology of MS and relevant animal models.
  • Experience in establishing and using neuronal models in vitro for drug discovery.
  • Ability to isolate subsets of neurons and establish primary cultures, including co-cultures and myelinating cultures.
  • Experience with in vitro electrophysiology of cultured neurons strongly preferred.
  • Experience in biochemical assays, in vitro pharmacology, including dose response, PK/PD, kinetics, mechanism of action and preclinical proof of concept studies.
  • Knowledge of neuroanatomy

Associate Director, Pharmacology and Pharmacokinetics Direct Hire MA

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Job ID: 15218 Direct Hire MA

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Global Biologics Company here in MA is looking to add an Associate Director, Pharmacology & Pharmacokinetics to their team!  This will be a non-lab based role focused on supporting nonclinical in vivo pharmacology research and development programs. The primary responsibilities of this position will include leading small project teams focused on in vivo nonclinical pharmacology studies, transitioning into preclinical development, clinical development and internal life cycle management activities.

Individual is expected to contribute to developing the strategy for nonclinical and clinical development (for biologics-related initiatives), preparation of regulatory documents and meetings with regulatory authorities. He/she will also provide functional and strategic support to teams developing biotherapeutics for various indications. Individual will maintain a close collaborative partnership with members of the Quality, Clinical, Regulatory and Rare Disease development and commercial units.

Requirements; 

  • PhD degree in Pharmacology, Biological Science, or a relevant scientific field, and 7-10 years of industry experience in Biotherapeutics. 
  • Experience contributing to regulatory filings required (IND, BLA, etc.).

Sr. RA/Associate Scientist, Molecular Microbiology Direct Hire MA

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Job ID: 15170 Direct Hire MA

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Our client is an extremely well-funded, early-stage biotech company developing the next wave of innovative biologics to treat patients. They are looking for an experienced Senior Research Associate/Associate Scientist, Molecular Microbiology with relevant academic or industry experience to join their growing team! This is a full-time, permanent career opportunity and will be hands-on in the lab developing and executing assays, troubleshooting experiments, and presenting results for mixed microbial community quantitation and phylogenetic analysis.

Main responsibilities include but are not limited to:

• Developing qPCR and next-generation sequencing based assays and optimize conditions for DNA and/or RNA extraction 
• Evaluating various microbial populations and isolates for identification and phylogenetic post-hoc analysis
• Authoring SOPs for routine performance of these assays and assist as needed with validation protocols
• Analyzing data (tracking and trending) for viability and non-viability determination
• Receiving training for cGMP and early-stage clinical trial production

Requirements:

• Must have a Bachelor's with 7-10+ years or Master's with 3-5+ years of academia and/or industry experience in molecular microbiology, molecular bio, microbiology, genomics, or related life science field
• Previous experience working with cutting-edge technologies and techniques for DNA/RNA assay development and nucleic acid extraction (qPCR, RT-PCR, RNAseq, NGS, etc.)
• Keen ability to plan experiments, analyze complex data sets, troubleshoot experiments, and present results/reports
• Good Laboratory Practices (GLP) and/or current Good Manufacturing Practices (cGMP) is a plus

Candidates must be authorized to work in the US indefinitely to be considered. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients. Formal descriptions can be supplied for interested candidates.

Senior Scientist, Molecular Microbiology Direct Hire MA

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Job ID: 15169 Direct Hire MA

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Our client is an extremely well-funded, early-stage biotech company developing the next wave of innovative biologics to treat patients. They are looking for a Senior Scientist, Molecular Microbiology with relevant academic or industry experience to join their growing team! This is a full-time, permanent career opportunity and will be hands-on in the lab.

Main responsibilities include but are not limited to:

• Developing qPCR and next-generation sequencing based assays and optimize conditions for RNA and DNA extraction 
• Evaluating various microbial isolates for identification and phylogenetic post-hoc analysis
• Authoring SOPs for routine performance of these assays
• Spearheading data tracking and trending for viability and non-viability determination
• Receiving training for cGMP and early-stage clinical trial production

Requirements:

• Must have PhD in Genetics/Genomics, Molecular Biology, Microbiology, or related field with 3+ years of relevant postdoc and/or industry experience
• qPCR assay development expertise (primer design, library construction, validation, etc.)
• Experience working with cutting-edge technologies and 16S rRNA
• Keen ability to plan experiments, analyze complex data sets, troubleshoot experiments, and present results and reports to senior management
• Good Laboratory Practices and/or current Good Manufacturing Practices a plus

Candidates must be authorized to work in the US indefinitely to be considered. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients. Formal descriptions can be supplied for interested candidates.