Scientist/Manager, Translational Science and Biomarkers

JOB DESCRIPTION

The role of Scientist/Manager Translational Science and Biomarkers will report to the Senior Director of Translational Science and Biomarkers, and work towards the successful execution of both clinical biomarker programs and pertinent translational science investigations. The ideal candidate will have both strong laboratory skills and clinical biomarker experience, is detail-oriented and self-motivated, with highly relevant experience.

Volastra is a fast-paced biotech company of passionate employees, and there is ample opportunity for the ideal candidate to grow and develop with the organization. Individuals will from time to time have the opportunity to gain experience with projects outside their direct scope of work. 
 
Job is based in NYC and requires a minimum of 60% in office time.

RESPONSIBILITIES

• In collaboration with the Translational Science and the Discovery Science teams, design and execute experimental plans to answer important translational questions to inform clinical development.
• Develop, validate, and implement biomarker assays that will inform preclinical programs and their translation to the clinic.
• Develop, validate and implement assays for biomarker measurement of clinical samples.
• Work closely with the cross functional Clinical Development team to integrate these biomarkers into clinical trial design, and ensure execution of biomarker plans for assigned clinical studies.
• Coordinate and oversee studies at contract research organizations. 
• Work closely with Clinical Operations team to operationalize biomarker sample collection, track samples, and ensure that clinical samples are analyzed as planned.
• Assist in preparation of relevant documents and reports including meeting presentations, biomarker reports, and regulatory submission documents. 

REQUIREMENTS

• MS in related field, PhD a plus but not required.
• 5+ years of hands-on lab experience with a range of relevant research techniques including cell-based assays, molecular biology, and histology.  In vivo mouse experience is preferred.
• 2+ years of clinical oncology biomarker experience including assay implementation, operationalizing clinical biomarker plans, sample management, sample analysis, and data delivery.
• Experience in the development and validation of biomarker assays suitable for clinical samples.
• Experience in coordinating operational activities including clinical sample tracking.
• Track record of successfully managing external projects with CRO’s from scoping to final data delivery.
• Understanding of the drug development process from target identification to marketing authorization.
• Basic understanding of regulatory aspects of medical diagnostics.
• Excellent communication, organizational, and problem-solving skills.

SALARY RANGE

Approximately $110,00-$155,000 which may vary depending on qualifications, experience, and ultimate leveling. Leveling outside of that stated may be considered for exceptional candidates on a case-by-case basis.