Clinical Safety Director
Location: White City, London
At Quell we seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.
Quell was founded in March 2019 in partnership with six prominent immunological experts from King’s College London, University College London, and Hannover Medical School, and is led by Iain McGill, a leading pharmaceutical executive with extensive relevant experience, having spent most of his 25 years in the industry in immunology, including the areas of solid organ and cell transplantation. The Company was founded with initial series A financing, led by Syncona Ltd who committed £59M with a further £2M contributed by UCL Technology Fund.
Clinical Safety Director
Early Clinical Development / Translational Medicine
Quell therapeutics, a pioneer and leader in Treg cell therapies, is an exciting, growing biotech company where you will find highly talented people who live and breathe our culture and support you in your personal growth. Quell therapeutics is entering clinical development by the end of this year bringing next-generation cell therapies to patients.
The Clinical Safety Director will orchestrate and implement relevant Safety-related Medical Activities in early Clinical Drug Development, particularly Medical Monitoring, Safety Management and Translational Medicine strategies.
- Providing key Medical Expertise for all relevant activities in Early Clinical Development with a focus on Medical Safety, including Clinical Trial risk assessment and mitigation strategies, Drug Safety Surveillance, signal detection, AE/SAE/SUSAR monitoring/reconciliation/narratives and interpretation of efficacy data from clinical trials.
- Providing medical input for Development Safety Update Reports (DSUR), Clinical Development Plans (CDP), Clinical Study Protocols (CSP), Health Authority interactions and Investigator’s Brochures (IB).
- Close interaction and alignment with relevant Contract Research Organizations (CROs), including Clinical Trial Safety monitoring, pharmacovigilance, medical monitoring, safety management plans, risk management plans and communication with investigators and clinical trial sites.
- Collaboration with internal and external cross-functional team members. Providing Medical Expertise and Clinical Safety training for internal teams, clinical trial sites and other relevant stakeholders. Develop and implement SOPs and workflows applicable for Medical Monitoring and Safety Management.
- Providing updates of the drug’s safety profile to Senior Management and develop pharmacovigilance / risk management strategies to enable informed and risk-based decision making in early clinical development.
- In close alignment with R&D, Clinical Operations and BD&L teams co-design clinical Drug Development Strategies (Translational Medicine approaches, forward/reverse translation, risk-benefit profiles, mechanism-indication matchings, TPPs)
- Interaction with Data Safety Monitoring Board (DSMB), contribute to DSMB meetings.
- Serve as Responsible Person for Pharmacovigilance (RPPV)
- Contribute to MedDRA coding and reconciling MedDRA codes with EDC
- Reporting to the CMO
- MD degree with 5+ years of Clinical Research Experience in CRO, Biotech or Pharma
- Preferably Clinical Experience in Transplantation, Hepatology, and/or Rheumatology
- Familiar with ICH/GCP frameworks and Pharmacovigilance
- Preferably ATMP experience
- Work flexibly within cross-functional matrix teams
- UK-based (Hybrid-working/WFH options)
- Ability to work collaboratively within a team, supporting one another and held accountable for project deliverables
- Team player with an agile “can-do” mindset
- Professional and personable verbal and written communication skills
- Driven to solve problems pragmatically in an innovate way
- Take pride and respect in leading a team effectively and efficiently
- Desire to work with integrity and act as an ambassador for Quell and the wider business
- Strong work ethic and a team orientation
- Holidays: 25 days per year
- Life Assurance: 4 x base salary
- Group Personal Pension: Auto enrolled at 4% employer contribution, 4% employee contribution
- Private Medical Insurance for your whole family
- Annual Bonus
- Fantastic collaborative environment at Translation & Innovation Hub
- £61 Million Investment including brand new lab equipment, innovative methods, and exposure to cutting edge technology
- Flexible working
- Fast paced and progressive company looking for future leaders and innovators