Stevenage or United States (Hybrid)
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 Principal Scientist/Director Drug Metabolism and Pharmacokinetics (DMPK) reports directly to the Chief Scientific Officer and is responsible for implementing an integrated DMPK strategy to support the preclinical and clinical development of pipeline programs.
Key responsibilities and learning opportunities
- Represent DMPK as the subject matter expert on multidisciplinary project teams, providing technical, scientific, and strategic leadership for all stages of drug discovery and early development
- Establish and implement DMPK strategy to define PK/PD relationships to advance a pipeline of novel therapies
- Collaborate with Pharmacology and Bioanalytical groups to help build a holistic research strategy
- Perform DMPK activities including interactions with external CROs and project stakeholders
- Lead the review, analysis, and interpretation of data from a wide range of sources to enable program go/no-go decisions
- Plan, secure, and manage PK workflows for IND enabling activities including contributions to regulatory filings
- Occasional lab work with a flexible location (based either in Stevenage or the US)
- Reports to CSO
Qualifications and Experience:
- Holds a PhD with 7+ years of industry experience
- Relevant scientific discipline such as drug metabolism, pharmacology, pharmaceutical sciences
- Broad and in-depth understanding of DMPK science with additional knowledge of related disciplines
- Experience working on DMPK drug discovery and/or development projects as a DMPK representative with a track record of problem solving and successful delivery across drug discovery
- Hands-on experience in PK, PK/PD modeling platforms (e.g., WinNonlin), and/or physiologically based pharmacokinetics (PBPK) analysis and modeling would be preferred
- Significant experience running and managing studies via external collaborators/CROs, and in data management and report generation.
- Familiarity with working in a regulated environment and contributing to regulatory filings
- 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/3maUQoK). 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.