Job Description
Job Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Function independently as a Project Scientist, Principal Investigator, Contributing Scientist in the direction and execution of assigned studies in compliance with regulations as they apply to the conduct of preclinical and clinical research. Provide scientific expertise in study conduct, design, and interpretation.
• Participate in and coordinate all phases of the study planning process with appropriate departments.
• Develop assays, generate high-quality laboratory method, protocols, amendments, reports, and facilitate appropriate changes to study design for assigned projects and programs.
• Review, interpret, integrate, and present data on assigned studies.
• Writes and edits draft or final reports that document all study related procedures and results.
• Analyze scientific problems, troubleshoot analytical methods and technical issues.
• Function independently as the point of contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.
• Provide prompt verbal or written communication with Sponsors on study related business.
• Mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and execution of validation studies.
• Provide technical and scientific guidance to the research staff.
• Contribute to testing of new biomarker technologies or introduce improvements in existing technologies.
The pay range for this position is between $100,000 to $108,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
QUALIFICATIONS:
• Education: Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master's degree (M.S./M.A.) or PhD/DVM preferred.
• Experience: Minimum of 6 years related experience in the development and/or validation of biomarker, PK and ADA assays is preferred (eg: ligand binding assays, enzymatic assays, Luminex, Bioplex, MSD, Quanterix Simoa, ProteinSimple Ella). Experience in a contract research organization is preferred.
• Other: Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations. Experience with Watson LIMS (preferred).