Careers

Clinical Operations Director at Magenta Therapeutics
Cambridge, MA, US
Description:

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.

Responsibilities:

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.
Requirements:
· 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.