Clinical Operations Director at Magenta Therapeutics
Cambridge, MA, US

We are currently seeking a dynamic Clinical Operations Director to manage early clinical development operations (Phase I/II clinical trials) for cell-based therapy. This key person will develop and implement the clinical planning process as well as development of integrated clinical development, including strategy, timelines, risk plans and budget/resources. Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational deliverables and timelines are met across the portfolio.


Overall operational management of early clinical development studies, including:
· The evaluation and oversight of clinical sites.
· Development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filing.
· Data collection and retrieval, liaising with data management, and query resolution and collection. Coordinate preparation of study protocols and final study reports.
· Managing all aspects of study progress from start-up to close-out activities to assure adherence to intended timeline to achieve study goals while ensuring good clinical practice compliance in accordance with FDA, EMEA, GCP, and ICH guidelines.
· Coordinating interdisciplinary activities and collaborate with the development team to formulate strategies and set goals/timelines, oversight and management of CROs to ensure successful clinical trial conduct by overseeing study activities to ensure data integrity and quality.
· Bachelor’s degree plus 5 years directly relevant experience
· A detailed understanding of overall strategic direction, interrelationships and business needs
· Experience is Cell/ Gene Therapy strongly preferred; experience with orphans indications and/ or stem cell transplantation will be favorably considered
· Management of CROs with multiple vendors and complex protocols
· Extensive experience in the pharmaceutical or related industry with proven Phase I study experience is essential Phase II and III experience is desired
· Knowledge of Good Clinical Data Management Practices, Medical Terminology, & GCP necessary
· Must have sound knowledge of the entire drug development process, including clinical plan development, study areas and execution of the entire clinical study chain
· Ability to organize and manage multiple priorities required
· Excellent oral and written communication skills required
· Ability and willingness to travel 25% of the time

We offer competitive compensation along with a comprehensive benefits package. To apply, please submit your resume.