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Are you driven to innovate? Passionate about making a difference?
Join the AVROBIO team.
Reporting to the Clinical Operations Lead, the Sr. Clinical Trial Manager will be responsible for the planning, implementation, and oversight of AVROBIO’s clinical trials. This position will ensure efficient and timely execution throughout the lifecycle of the clinical trials in compliance with SOPs, Regulatory Authorities, and ICF/GCP guidelines.
The Senior Manager/Associate Director, Regulatory Affairs integrates and applies knowledge of US and ex-US regulatory guidelines to AVROBIO’s pipeline development programs. Ensures global strategies are successfully implemented and executed across AVROBIO’s portfolios. Interfaces cross-functionally both within AVROBIO and external service providers/partners. Participates as a member of the project program development team(s) to build awareness of Regulatory Authority requirements and timing for submissions. Demonstrates leadership and has comprehensive understanding of global regulations and
The Head of Quality is responsible for strengthening, further development and execution of AVROBIO’s quality assurance program and management systems, in support of all clinical development, pharmacovigilance, supply chain and manufacturing activities. He/she will direct GxP Quality related activities across the organization to support pivotal studies, global regulatory submissions (NDA/MAA, etc) and ultimately commercial launch of products. The Head of Quality will build and lead an internal team and supplement as necessary with external consultants/contractors to support QA activities, and
The Associate Director/Director, Program Management will be responsible for providing tactical and strategic leadership of the company's development programs. Ideal candidates will demonstrate strength in communication and organizational skills to succeed in a role that is highly cross-functional and broadly engaged across the company. In this position you will bring strong drug development experience and the ability to build and deploy tools and best practices to ensure the successful execution of an R&D program at a rapidly growing organization.
The Director/Senior Director, Supply Planning & Systems will establish and build the Supply Chain Planning & Systems function working closely with Quality, Manufacturing, Regulatory Affairs, Clinical Operations, Commercial and Portfolio Management. This leader will ensure AVROBIO is well positioned to meet development, clinical and commercial material/production needs. The position requires a goal-oriented individual who is a positive influence and role model that embraces change, possess a continuous improvement mindset, and has the passion for exceeding function, company, and customer
*Role can based at our Cambridge, MA or Toronto, Ontario locations. The role can also be remote in the U.S. or Canada.
The Global Head of Drug Safety will be responsible for the strategic implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the AVROBIO’s development and future looking commercial activities. They must effectively collaborate cross-functionally at all levels in the organization as well as external safety service providers and regulatory authorities.
The Global Head of Drug Safety will lead and is accountable for
The Manager, External Manufacturing will play a key role in the partnership and management of CMO activities. The role will help review and optimize assays over multiple CMOs. The Manager, External Manufacturing will also provide general oversight and management of CMOs.