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Role Summary:
We are seeking a highly skilled and motivated Senior Scientist to join our growing team at Spyre. This function will utilize biomarkers to help identify populations more likely to respond to Spyre’s drug candidates, establish evidence of drug exposure and target engagement, and assess response, with an emphasis on the molecular impacts of combination therapy. The Senior Scientist will be responsible for multiple biomarker aspects including oversight of biomarker assay development and validation at external vendors, biomarker lab manual development, biomarker sample management, biomarker data generation and analysis across Spyre’s pipeline and may serve as the biomarker lead on certain development programs. This individual will be a key member of the team driving execution of Spyre’s translational strategies to support the development of Spyre therapeutic antibodies. Substantial effort will be spent directing biomarker assay development and validation at CROs and generating clinical biomarker sample analysis and data analysis in a variety of written reports or other documents. This role will report to the Sr. Director & Head of Translational Science and interact with multiple other functional teams within Spyre (Clinical, Clinical Operations, Nonclinical, Quality, Project Management, Regulatory, etc.)
Key Responsibilities:
• Contribute to the design, development, validation, operationalization, and execution of clinical biomarker assays in accordance with relevant regulatory requirements including review of literature and assessment of compliance, when appropriate.
• Recommend and oversee CROs executing all biomarker analysis related to target engagement, mechanism of action, pharmacodynamics. Experience with bioanalysis is a plus.
• Travel to and scientifically evaluate vendors/CROs for the purpose of conducting a variety of studies related to biomarker activities.
• Communicate plans, progress, and results of key studies to internal and external audiences via written and verbal means.
• Work closely with project management, biostatisticians, data scientists, and outside consultants, and other stakeholders to ensure delivery of high-quality biomarker data.
• Deliver high-quality biomarker data packages as required for successful regulatory approval and commercialization.
• Serve as Translational Science representative on a multidisciplinary team of R&D professionals to progress therapeutic molecules in the clinic.
Ideal Candidate:
• PhD or equivalent experience in relevant discipline (e.g., pharmacology, immunology, or another relevant field)
• 4 years of translational science and/or drug development experience with complex biologics spanning early development.
• Experience with different biomarker assay platforms: flow cytometry, ligand-based assays, transcriptomics etc.
• Experience with CRO engagement and oversight a plus.
• Excellent communication skills with an ability to present to a variety of stakeholders and adjust message for maximum understanding of all parties.
• Strong leadership mentality, willing to learn from others, and dedication to being an excellent colleague within Spyre and with our key partners.
• Detail-oriented, with good organizational, prioritization, and time management skills.
• Ability to multi-task and keep pace with a fast-moving organization.
• Ability and willingness to travel at least quarterly in support of team objectives and goals.
What We Offer:
The expected salary range offer for this role is $133,000 to $159,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
Full Time
$151k-185k (estimate)
04/21/2024
05/05/2024