Job Title: Associate Director, Safety Science

PsiOxus Therapeutics Ltd is an award-winning UK/US development stage biotechnology company developing novel “tumour re-engineering” therapeutics for the treatment of cancer, with a focus on immunotherapeutic approaches.  We currently have two transgene-expressing T-SIGn cancer gene therapy candidates in Phase I/II clinical development and are further developing our innovative platform technology and pipeline of new pre-clinical and research candidates. We have active collaborations in the UK & USA, including Bristol Myers Squibb, bluebird bio (Boston) on T-SIGn combinations with CAR-T cell therapy and with the Parker Institute for Immunotherapy (San Francisco).

We are looking for a talented safety scientist who can lead the pharmacovigilance and safety science function at PsiOxus. You will apply your pharmacovigilance, oncology, and scientific experience to lead the safety strategy for complex, advanced therapy medicinal products in early clinical development.

In this role you will work collaboratively with colleagues in clinical development and research to lead the analysis and interpretation of clinical data to support the development of the PsiOxus T‑SIGn vector platform.  You will lead pharmacovigilance operations at PsiOxus, including overseeing vendor performance.

The role offers significant potential for personal and professional development as the PsiOxus T‑SIGn vector platform advances through clinical development.

Responsibilities include but are not limited to:

• Develop and maintain a deep understanding of the safety profile of the PsiOxus T‑SIGn vector platform
• Lead signal detection and management activities.  This includes aggregating, reviewing, analysing, and interpreting clinical data to support safety decision-making
• Use data analytic tools to analyse raw data and identify emerging safety signals or trends
• Define the product safety strategy and provide safety input into the Clinical Development strategy including protocols, investigator brochures, informed consent, study reports and development safety update reports
• Lead the internal Safety Assessment Committee
• Act independently to manage safety responsibilities on project teams and in activities supporting safety science
• Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
• Lead pharmacovigilance operations e.g., safety plans, pharmacovigilance agreements, budget, compliance
• Oversee safety case processing and preparation of aggregate reports by external vendor
• Oversee and maintain the PsiOxus Pharmacovigilance system.

Candidate requirements

• Life Science Degree or higher
• A minimum of 3-years relevant experience in a pharmacovigilance or safety science role
• In depth knowledge of pharmacovigilance requirements in the US and Europe
• The ability to demonstrate a broad understanding of the scientific aspects of pharmacovigilance and clinical risk management
• The ability to apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
• The ability to understand complex medical and scientific data from a broad range of disciplines e.g., clinical laboratory data, nonclinical data, scientific literature
• Demonstrated ability to lead and influence in a matrix environment.

We are looking for someone who has strong oral and written communication skills and can work collaboratively as well as having excellent organisational and project management skills.

This is a fantastic opportunity to join our team and have an impact on the health and well-being of people with cancer. In return we'll help you build a career that you can feel passionate about.  If you would like to apply please visit our website and ensure you upload a covering letter and CV, explaining why you are interested in this position.  In return we offer a great working environment, an attractive remuneration package and a range of competitive benefits including:

• Competitive salary and discretionary bonus scheme
• Private medical insurance including optical and dental
• Critical illness cover
• Income protection
• Life Insurance
• Pension
• Various offers via Perkbox including Nuffield annual health assessments
• 25 days holiday and the option to buy 5 additional days
• On-site parking

The closing date for applications is 4th February 2022.  There will be a 2-stage interview process, first via Teams and second on-site.

As part of our background screening process, we conduct Basic DBS checks on successful candidates.

Only shortlisted candidates will be contacted.