Mission Therapeutics is an early-stage drug development company targeting the ubiquitin pathway for the treatment of neurodegenerative disease, rare mitochondrial diseases and fibrosis. The Company has built a leading platform for the discovery and development of first-in-class, small molecule drugs that selectively target deubiquitylating enzymes (DUBs) – an emerging drug class that is attracting significant commercial interest in the area of protein homeostasis.
The Head of Non-Clinical Safety will contribute to the optimization of new chemical series and selection of novel candidate drugs. She/he will be responsible for the non-clinical safety support of all development programs at MISSION, with a particular focus on toxicology project support. Core responsibilities include non-clinical safety plans for development programs, and toxicology/safety pharmacology study design and oversight in support of INDs, data interpretation and presentation, as well as preparation and review of non-clinical safety related regulatory documents and submissions.
Key Responsibilities of the role will include
• Responsible for the safety strategy in multi-disciplinary drug-hunting project teams. Lead drug safety to influence project decision making with the aim to deliver molecules with the “Right Safety” profile.
• Designs project-specific in vitro and in vivo strategies to predict, assess and mitigate target- and drug-related safety risks and execute through internal and external experimental capabilities.
• Engages with world-class experts to develop, refine and implement innovative experimental strategies and use the data to assess and/or provide mechanistic understanding of safety issues.
• Develops innovative solutions and research proposals to pursue cutting edge science and technologies in order to optimize and influence safety assessment of novel drug targets.
• Leads development and execution of non-clinical safety drug development plans for novel therapeutics in accordance with appropriate ICH, FDA, and EMA guidelines.
• Identifies and interprets non-clinical safety findings as they relate to clinical drug safety
• Prepares and/or reviews nonclinical safety portions of CTA/IND submissions, Investigator Brochures, IMPDs, briefing packages for regulatory meetings.
• Represent Mission nonclinical safety at regulatory meetings when required.
• Advises discovery programs and support exploratory non-GLP studies for these programs.
• Working with Study Monitor, responsible for contracting and monitoring of GLP and non-GLP toxicology/safety pharmacology studies across all stages of development. This includes establishing timelines, CRO selection, contract negotiations, protocol preparation and review, study conduct, and monitoring, report preparation, and report review and finalization.
• Integrates findings from pharmacology, clinical pharmacology, DMPK, toxicokinetic and toxicology studies to project margins of safety.
• Manage Study Monitor, potential to manage Senior Safety Scientist in the future.
Qualifications, Skills and Experience
• PhD-level education (or equivalent experience) in pharmacology, toxicology, pathology or a related scientific discipline
• At least 10 years in pharma/biotech/CRO non-clinical safety environment
• Ability to excel in diverse multidisciplinary teams
• Demonstrated ability to provide innovative solutions to safety and toxicological issues/risks
• Strong communication skills with colleagues and stakeholders across seniority grades
• Excellent presentation skills
• Highly autonomous and able to work independently
• Willingness to take accountability
• Commitment to internal and stakeholders
• Self-aware of professional strengths and experience gaps
• Willingness to seek guidance/consultation when required
We offer a competitive salary along with a contributory pension scheme and other excellent benefits.
If you would like to apply for the position, please send your CV with a covering letter to email@example.com.
The closing date for applications is 31 January 2022.
In order to comply with UK employment legislation, all applicants for positions at Mission must have the right to work in the UK. In the event that a job offer is made, you will be required to provide evidence of your right to work in the UK before you commence employment with Mission.
All applications received will be managed in accordance with our Job Applicant Privacy Notice available to view on the Careers page of our website www.missiontherapeutics.com
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