Remote, US (preferred) or UK
Complement Therapeutics (CTx) is an exciting early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.
Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for dry age-related macular degeneration/geographic atrophy, a leading cause of blindness. Additional programmes will evaluate potential therapeutic opportunities in other complement-mediated conditions.
The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.
This is an exciting opportunity to join the Company in a pivotal strategic role to drive the non-clinical development of our novel pipeline.
The role of Director Toxicology will possess expertise in the drug discovery process and will provide leadership in supporting the nonclinical safety evaluation of CTx’s pipeline products. The Director reports directly to the Chief Scientific Officer and will design, execute and interpret non-clinical safety studies with other cross functional program representatives (including DMPK, bioanalytical, pharmacology).
Key responsibilities and learning opportunities
- Oversee toxicology strategy for pipeline candidates and manage nonclinical workflows in collaboration with Bioanalytical, Pharmacology and DMPK functions.
- Evaluate new targets for potential toxicological liabilities.
- Provide expert support to discovery and development projects to support the development of pipeline products, interactions with health authorities and regulatory submissions.
- Maintain awareness and application of Regulatory requirements relating to nonclinical toxicology studies.
- Design and interpret toxicology data from investigative, non-GLP and GLP-compliant toxicology studies to support clinical development.
- Reports to CSO
Qualifications and Experience:
- Holds a PhD with 7+ years of industry experience.
- Significant expertise working in a regulated environment and demonstration of delivering successful IND-enabling nonclinical programs.
- Experience in designing nonclinical safety strategies for projects from candidate nomination to GLP toxicology studies with particular expertise in NHP models
- Significant experience running and managing studies via external collaborators/CROs, and in data management and report generation.
- Excellent understanding of drug development, regulatory principles and clinical development requirements including GLP and 3Rs
- Understanding of complement biology and/or ophthalmology preferred
- Project and people management
- Cross functional experience in clinical development programs
- Excellent organisational and communication skills, both written and oral
- A self-starter, self-motivated individual who is adept at working in fast-paced environments
Please fill in this form (https://bit.ly/3Z7WFBd). You must also include a cover letter detailing why you are interested in joining a biotech start-up and then Complement Therapeutics in particular. Your cover letter should be no more than one page of A4.