You are viewing a preview of this job. Log in or register to view more details about this job.

Study Director, In Vivo Oncology

JOB SUMMARY:
The Study Director is responsible for managing all phases of animal studies ensuring company strategies are implemented and company goals are achieved.

PRIMARY RESPONSIBILITIES:
• Provide expertise in areas of design, implementation and analysis of in vivo, in vitro, or toxicology studies
• Responsible for reviewing pre-clinical data
• Provide hands-on technical execution of studies if required
• Provide study design and effective protocol development
• Develop, approve, and distribute study-related documents and other study tools
• Oversee study planning, initiation, and study-closure processes
• Create metrics, complete data analysis, study reports and presentations
• Act as key point of contact and facilitate communication across Crown Bioscience departments, providing relevant information
• Act as key point of contact for Crown Bioscience customers by providing regular updates
• Review adverse events for safety and effectiveness information
• Track and report progress of studies
• Provide quality checks of study plans and reports, assisting QA with the development and implementation of corrective actions for addressing noncompliance issues
• Maintain familiarity with current literature and trends
• Prepare and present protocol and general study information to Clients and internal meetings
• Conduct work activities in compliance with all relevant regulations including ethics, environmental health and safety, financial, human resources, SOPs, and general business policies, requirements and objectives

EDUCATION, KNOWLEDGE, AND EXPERIENCE REQUIREMENTS:
• Requires a PhD in Biomedical Science or a related discipline or MS with at least seven years’ experience
• Requires 1-2 years of Post Doc translational biology/oncology experience in a research and/or clinical environment
• Requires significant experience in oncology-related animal studies, preferably small molecules, biologics and immuno-oncology
• Experience in a CRO setting and ability to multi-task, manage customer projects, and customer interactions is preferred
• Demonstrated experience leading teams and driving results
• Strong understanding of oncology target biology and contemporary cell biology approaches to drug discovery
• Willing and able to work under the pressure of deadlines and find solutions to meet timelines
• Ability to work across teams by being a flexible team player with strong communication and interpersonal skills
• Willing and able to work within a Quality System with oversight by QA and other regulatory bodies
• Exceptional organizational and time-management skills
• Ability to multi-task with a high degree of professionalism and diplomacy

WORKING CONDITIONS and PHYSICAL REQUIREMENTS:
• Sitting for long periods of time
• Prolonged computer usage
• Able to lift up to 20lbs
• BSL-2 Lab Environment
• Normal office environment