Study Director: Translational Oncology

Description:

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