Director of Toxicology £Competitive Salary and Benefits Package
Arecor Ltd is a leader in developing superior biopharmaceuticals through the application of an innovative formulation technology platform. Arecor is currently leveraging this platform to develop a portfolio of proprietary products that will enable improved treatments for diabetes via the innovative reformulation of approved proteins and peptides. Arecor’s product portfolio also includes:
• Stable aqueous glucagon for emergency and artificial pancreas use,
• Novel insulin formulations to deliver ultra-rapid acting insulin analogs and;
• Ultra-concentrated rapid acting insulin to enable the miniaturisation of devices.
In addition to its internal product portfolio, Arecor partners with leading pharmaceutical and biotech companies to deliver superior reformulations of their proprietary products, which would otherwise not be possible using conventional formulation science.
An exciting opportunity on the Arecor Management Team has become available as Director of Toxicology. The position requires experience in designing, planning, conducting, monitoring, interpretation of results and reporting of non-clinical safety studies in collaboration with project teams. Ability to provide expert scientific leadership in non-clinical pharmacology and toxicology for the Arecor portfolio of early stage products. Significant product development experience in running non-clinical safety studies at a pharmaceutical or biotechnology company is required. Experience in diabetes and/or peptides would be advantageous but not essential. Familiarity with GLP regulations and regulatory guidelines for testing, and experience with compilation of toxicology information into various regulatory submissions documents is required. Excellent communication skills are required.
The Director of Toxicology will:
• Develop the non-clinical strategy for Arecor’s portfolio of early stage products and advise for Arecor’s partnered programs
• Design, conduct and report of non-clinical safety studies
• Identify, assess and audit CRO facilities for studies to be conducted
• Act as Study Director, Study Monitor and Principle Investigator for non-clinical safety studies delivering on budget and on time
• Prepare regulatory documentation (CTAs, IMPDs, INDs, NDAs etc) and interact with authorities as needed
• Communicate toxicology data to project teams and ensures delivery in line with product development plans
• Provide budgeting and forecasting information to the overall project budget
• Identify risks to the pre-clinical safety plan, proposing options for resolution/mitigation
• Maintain toxicology expertise, keeping up to date with scientific literature, attending and contributing to scientific meetings
• Education, PhD in Toxicology or Biomedical Sciences
• Experience, 7+ years post PhD experience in a pharmaceutical or biotechnology company or CRO managing toxicology studies
• Ability to interact successfully in a cross functional team setting
• Experience working with common toxicology species
We operate from a high quality laboratory facility on the Chesterford Research Park which offers excellent on-site facilities www.chesterfordpark.com
Please forward your covering letter and CV to: Sheridan Cook, Office Manager email@example.com.
DEADLINE for applications 28th September 2018 STRICTLY NO AGENCIES- Thankyou