Study Director – Pre-Clinical Cardiovascular and Metabolic Diseases
Location: US, Louisiana
Position: Full Time
We are looking for an outstanding researcher with a passion for cardiovascular and metabolic diseases! We have an immediate opening for a full-time Study Director working in our Pre-Clinical CVMD Department.
We are a world-class biopharmaceutical service partner. Our mission is to help our clients investigating their novel therapeutics and increase the success of their clinical trials. We offer fully-integrated pre-clinical solutions for the discovery and application of chemicals and biologics that will be beneficial to patients suffering diseases such as diabetes and complications and heart failure. If you share these values and passions, this is the environment for you.
The Study Director is responsible for managing rodent studies ensuring company standards are implemented and company goals are achieved. The Study Director will provide expertise in areas of design, execution and analysis of in vivo mouse and rat CVMD studies and is responsible for QC of pre-clinical data and reports to control overall data quality before submitting to higher management and the client. The Study Director is also responsible for communications with client during study execution through emails and teleconferences. The Study Director will generate study protocol according communications with client, perform hands-on key experiments and surgeries, supervise study execution and QC data and results, review study data and report for regular communications with client.
- Provide hands-on technical execution of studies
- Maintain familiarity with current pharmaceutical research literature and trends
- Provide study design and effective protocol development
- Develop, approve, and distribute study-related documents and other study tools
- Oversee and responsible for study execution and results
- Create metrics, complete data analysis, study reports and presentations
- Manage procurement, distribution, collection, and tracking of study material including compounds, samples and supplies
- Act as key point of contact and facilitate communication across Crown Bioscience departments by providing study relevant information
- Act as key point of contact for Crown Bioscience customers by providing regular study updates
- Review adverse events for safety and effectiveness information
- Track and report progress of studies at weekly, biweekly or monthly meetings
- Provide quality checks of study plans, data and reports, assisting QA officer with the development and implementation of corrective actions for addressing noncompliance issues
- 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
Please note that this position will start at the Indianapolis site and transition the work over to CrownBio Louisiana within 2 to 3 months.
Education, Knowledge and Experience Required:
- Incumbents can meet qualifications for position with a combination of education and experience:
- Bachelor degree in biomedical science, physiology or related discipline, with 3-5 years cardiovascular and/or metabolic diseases experience in a research and/or clinical environment (CRO preferred)
- Master degree in biomedical science, physiology or related discipline, with 0-2 year’s cardiovascular and/or metabolic diseases experience in a research and/or clinical environment (CRO preferred)
- Requires significant experience in CVMD-related rodent studies, has hand-on experiences in cardiovascular surgeries, glucose/insulin tolerance tests, metabolic rate measurements or other related techniques
- Requires experience designing and executing research studies for peer-reviewed publication or FDA application, has knowledge and understands current research trends for diabetes and cardiovascular diseases
- Preferable to have experience in a CRO setting and ability to multi-task, manage customer projects and customer interactions
- Demonstrated leadership and results
- Experience with non-human primate disease models is a plus
We strive to provide a collaborative, creative matrix where each person feels encouraged to contribute to our processes, decisions, planning and culture. We are continuously looking for talents from various backgrounds to join us.