Certis is seeking a highly motivated and self-directed, Study Director that will :
Design, administer and interpret client-sponsored studies, serving as the primary scientific and operational liaison
Evaluate and integrate innovative technologies and methodologies that enhance translational relevance and accelerate therapeutic insights
Foster a collaborative environment by modeling strong scientific communication, proactive coordination, and high-quality study execution
Report to the Sr. Director of Scientific Operations for guidance on study milestones, financial approvals, and client strategy
Develop, amend, and oversee study protocols and related documentation to ensure clarity, compliance, and alignment with client objectives
Serve as the primary point of contact for internal and external study communications, providing consistent updates and guidance throughout the project lifecycle
Monitor multiple complex in vitro , ex vivo and in vivo studies by managing daily tasks schedules, data integrity, and resolution of study discrepancies
Calculate dosing regimens and formulations
Analyze and interpret study data with scientific rigor, preparing interim and final deliverables that highlight key insights and outcomes
Support the logistics and record keeping of sample shipments
Track study financial actuals, prepare costing reports, and support invoicing activities
Contribute to Certis’ scientific growth by researching, evaluating, and recommending new models, technologies, or partnerships that advance precision oncology and translational research
Requirements :
Ph.D. in Life Science related field preferred, MS required
3 years experience in managing oncology-related assays, and / or in-vivo immunology, pharmacology or related scientific studies
Experience preparing study protocols, amendments, and reports for studies.
Proficient in Microsoft Office Suite (Word, Powerpoint, Outlook) and StudyLog
Experience working with laboratory information systems / electronic notebooks
Experience in managing multiple projects and communications
Experience in a CLIA-certified environment preferred
Experience with IND preparation and submissions preferred
Direct management experience preferred
Vivarium experience preferred
Strong orientation to inclusive teamwork, attention to detail
Effective communication skills for a variety of stakeholders