Study Director: Translational Oncology

Job Description

Job Description

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

• 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