Director, Translational Medicine

Our Mission

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

We Have In-licensed Ivonescimab, Which Is a Novel, Potential First-in-class Investigational Bispecific Antibody Combining The Effects Of Immunotherapy Via a Blockade Of PD-1 With The Anti-angiogenesis Effects Associated With Blocking VEGF Into a Single Molecule. We Plan To Initiate Clinical Studies In The Following NSCLC Indications

• Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)
• Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)
  
  

Overview Of Role

Summit is seeking an enthusiastic translational scientist with excellent technical skills to guide immunotherapy and/or targeted drug candidates along the path to clinical development.

• Role and Responsibilities:
• Develop, formulate and execute on later-stage clinical development (Phase 2-3) biomarker strategy with potential for stratification/prediction of responses in immunotherapy and anti-angiogenesis bispecific antibodies in various solid tumors.
• Determine, design and develop preclinical/clinical biomarker assay with clear clinical utility in the disease setting, and work with CRO for assay qualification and validation.
• Design in vivo preclinical pharmacology PK/PD assays to understand drug mechanism of action, and dose activity correlations.
• Critically review, collate, organize and interpret large biomarker datasets from different platforms (genomics, transcriptomics, multiplexed IHC, flow cytometry, proteomics), summarize in reports and communicate within R&D.
• Provide clinical summary of drugs under clinical development in lung cancer and other solid tumors.
• Monitor biomarker/PD studies of immunotherapy at CROs including vendor selection/qualification, initiation/planning, study design, writing protocol/report, reviewing regulatory documents and managing budget.
• Contribute to drug discovery and translational medicine programs in oncology as needed.
  
  

Experience, Education And Specialized Knowledge And Skills

• PhD/MD with 3+ years postdoctoral training in cancer/cancer immunology preferentially in solid tumors/lung cancer, with minimum 5+ years working experience in early to late phase clinical biomarker/translational medicine in the pharmaceutical industry, a track record of peer-reviewed publications and patents that demonstrate productivity and independence.
• Experience or strong scientific understanding of biological basis of immunotherapy, angiogenesis pathways. Strong biochemical understanding of biologics and therapeutic drugs.
• 3-5+ years experience as biomarker lead in a clinical development team (preferentially Ph2/3) with understanding of biomarker study logistics and management
• Strong understanding of biomarker assay qualification/validation in immunotherapy
• Analytical experience with biomarker datasets
• Strong experience in several assay platforms/ instrumentation, including ctDNA/WGS assays, WES/RNAseq, transcriptomics, multiplexed IHC, BLI, antibody activity assays, ELISAs and other routine cellular/functional assays desirable.
• Expertise in inflammation/oncology in vitro pharmacology, in vivo animal model experience and flow cytometry
• Experience with biomarker analysis/programming/bioinformatics, use of Spotfire, ArrayStudio, LIMS system or other AI-assisted data analysis programs in digital pathology.
  
  

The pay range for this role is at the Director level is $200,000 - $245,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits

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