As part of building our team to drive our portfolio forward, we are seeking a scientifically and operationally strong Toxicologist with sound experience of early Phase translational research, who can lead CROs and external collaborators to deliver successful IND enabling studies supporting Freeline gene therapy programmes. The successful candidate will join the Translational Research Team and report to the Director of Toxicology.
Freeline places a strong emphasis on innovation and the desire to make a difference for patients, by applying your skills to develop novel gene therapeutics through collaborative multidisciplinary teams. We will provide you with promising and exiting development programmes in an environment that strongly values your development.
The successful candidate will join a rapidly growing world-class team and will have the opportunity to play a part in shaping the growth of this exciting new biotechnology Company.
Strong scientific background in Pharmacology and Toxicology to address key pharmacologic scientific questions, advancing projects from pre-clinical to early phase clinical development
Strong understanding of and experience with GLP toxicity requirements across different territories (e.g. EU, USA)
Understanding of the necessary preclinical data for a lead candidate to support IND/CTA, coupled with experience of working in cross-functional teams to support pre-IND drug development.
Ability to represent Freeline and strong experience working with external providers such as contract research organisations (CROs) and academic specialty laboratories.
Ability to direct and assess the work of a CRO to produce a high standard of work for ex-vivo and in vivo experiments
Exceptional analytical and problem-solving skills, with the ability to understand and interpret findings and to develop mitigation strategies for the successful progression of projects.
Willingness to travel both within the United Kingdom and abroad to evaluate capability of CRO and academic specialty Laboratories, support Regulatory meetings, as well as to present at conferences/workshops and other meetings
Qualification, Education and Experience Requirements
BSc in a relevant biological discipline or equivalent level of professional qualifications, with a minimum of 5 years of experience working in the pharmaceutical industry in a preclinical R&D environment
Experience with in vivo models in multiple species (rodent and non-rodent), as well as correlating in vitro/in situ systems with in vivo models
Has successfully led multiple GLP-toxicity studies, including protocol writing, study management and reporting
Excellent verbal and written communication and computer literacy skills, with the ability to write and present clearly and succinctly for regulatory documents, publication, for internal decision making
Personable and effective communicator, willingness to work as part of a multi-disciplinary team, to be open-minded, flexible and cooperative in a dynamic and fast-growing company
Effective time management with a commitment to meeting deadlines and appreciation for the impact of timing delays on the overall company's objectives.
Ability to assess resource requirements and deploy them effectively
Self-motivated with the ability to take initiative, organise and work autonomously, and to take on and drive new challenges
Prior knowledge on the execution of preclinical AAV studies using various in vivo model systems related to AAV gene therapy development to deliver high-value data and support all aspects of AAV-based gene therapy projects.