Here is an interesting blended role for a highly motivated and driven project manager with extensive hands on In Vivo experience. As part of the In Vivo Sciences team, you will be responsible for managing outsourced studies; designing, implementing and supporting the training program; and providing back up support to our Study Coordinator.
The Preclinical and Translational Development group works with bluebird bio’s discovery platforms and translational research teams to generate the hypotheses, mechanism-of-action, and efficacy data that fuel the bluebird pipeline. We also work with our clinical and regulatory teams to generate the toxicology and biodistribution data that is critical to translating each of bluebird’s innovative therapies safely from research into patients. In doing so, we continuously strive towards our mission to be the biotech world’s best preclinical development organization for immunotherapy and gene therapy. Our valued associates experience room to grow their careers, a supportive, flexible and collaborative work environment, and respect for a diversity of experiences and perspectives.
- Provide oversight and monitoring of in vivo pharmacology studies carried out at Contract Research Organizations (CROs).
- Serve as the key interface between bluebirdbio Preclinical and Translational Development Team and CROs for design and execution of outsourced studies.
- Ensure suitability of CRO for planned study, set up contracts and POs.
- Ensure IACUC protocol requirements are met.
- Ensure alignment and clear communication with relevant parties (in house teams, CRO).
- Coordinate timely supply of necessary materials to CRO.
- Conduct site audits and monitor studies as needed.
- Ensure timely sharing of information with the Preclinical and Translational Development Lead during the course of the study.
- Review preliminary data. Lead the timeline generation for review and finalization of reports.
- Develop, implement, monitor and refine the In Vivo training program.
- Provide “hands on” training in basic rodent in vivo techniques (dosing, bleeding, anesthesia, etc.) with support from other Subject Matter Experts.
- Serve as back up for the In Vivo Study Coordinator for the conduct of non-GLP and IND enabling preclinical studies across multiple science groups and IND enabling preclinical studies across multiple science groups
- Conduct business process reviews to ensure optimized resource utilization and operational efficiencies across the program.
Knowledge and experience working with; Microsoft Excel, Word, PowerPoint; Knowledge and use of Sharepoint and Studylog database software is a plus
- BA/BS or MS with 5-10 years’ experience in the biotechnology or pharmaceutical industry required
- Experience with preclinical study coordinating, study protocol generation, and weekly scheduling is preferred.
- Strong technical-scientific background with experience and understanding of in vivo study execution is required
- Project management experience with relevant certification (such as PMP, lean/six sigma certification) preferred
- Desire and drive to learn and understand the basic biologic mechanisms underpinning our immunotherapy oncology and gene therapy products
- Familiarity with programs such as Excel, GraphPad Prism, PowerPoint, and Studylog for data entry, analysis and presentation
- Team player with excellent oral and written communication skills and “do-what-it-takes” attitude
- Independently motivated, detail-oriented and excellent problem-solving abilities
- Excellent organizational skills towards multi-tasking in an extremely fast-paced environment with changing priorities
- Comfortable with rapidly changing schedules and priorities
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself