- Develop and implement the AutoImmune Translational Medicine strategy, including but not limited to making recommendation regarding biomarkers, assay development, endpoints, study design, safety evaluations, dose selection, and publications.
- Matrix work with other functional areas to define key aspects of the integrated development plans, including key early clinical translational steps in the development strategy (e.g. schedule of assessment, vendor selection and management, assay validation, companion diagnostic etc...).
- Develop close cross-functional relationships with other Autolus departments (R&D, development, manufacturing, medical affairs and commercial etc...)
- Matrix management of scientists and other translational staff supporting programs directly, nurturing a culture of engagement, respect and high performance within a team environment.
- Provide coaching and mentoring to members of the Translational Medicine team; in line with Autolus' values
- Write and author Translational-related sections within clinical study documents (i.e. investigator brochures, clinical study protocols and reports, regulatory submissions and responses (INDs/CTAs)), as well as co-authoring, assisting and supporting the development of publications, abstracts, and presentations.
- Serve as a key representative for external facing activities (e.g., CRO, KEE, Data monitoring Committees and clinical trial site members)
- Manage resources and make recommendation to enable Autoimmune projects, including assessment of workload, resourcing and budget requirements
Director/Senior Director, Translational Medicine – CAR-T Autoimmune - London, United Kingdom - Autolus Limited
Description
Role Summary
With an expanding translational medicine team, an exciting opportunity has arisen for a Director/Senior Director to join the team to support global expansion of our cell and gene therapy products. This position requires a Translational Medicine professional with expert knowledge of autoimmune diseases. The post holder will work within the Translational Medicine team and cross-functionally (medical directors, research scientists, regulatory, clinical operations, biometrics etc...) to lead the Translational strategy for Autolus' autoimmune franchise.
The successful candidate can work independently and within a proactive can-do culture. They will be an effective contributor in a matrix organization. Deep scientific rigor, a thorough understanding of experimental medicine, drug development and autoimmune disorders are key success factors. The candidate will be a highly effective internal and external team player, communicator, and collaborator.
This is a highly visible role in a growing company, providing the opportunity to lead key activities to support career progression.
Key Responsibilities
Provide high quality scientific leadership for all Translational activities of the Autolus Autoimmune franchise