Role Purpose
Silence Therapeutics is a leading biotechnology company specialising in gene silencing drugs. Our technology platform allows us to directly modulate the relationship between the genome and disease using siRNAs. Our clinical-stage programmes offering potential benefits to patients in a range of conditions. We are building our Clinical Science and Safety teams to power the development of our products in late-stage discovery and early-stage clinical development.
Role Overview
Reporting into the Head of Clinical Science this is a hands-on role for a talented, creative safety scientist who is enthusiastic about working with colleagues from other disciplines and applying their own skills to active, fast-moving drug discovery and development programmes. The Clinical Safety and Pharmacovigilance Associate Director will focus on the safety aspects of the development of SLN360 for patients with cardiovascular disease/ SLN124 for patients with haematological disease and SLN 501 for Complement mediated disorders.
Key Responsibilities
- Work closely with the Head of Quality and Clinical Safety to review and implement Pharmacovigilance processes and procedures where required
- Develop Pharmacovigilance SOPs
- Preparation of RFPs, and choice of safety vendors
- Oversight of safety vendors including design and monitoring of KPIs with ethos for continuous process improvement
- Work in tandem with safety physician at CRO for ongoing studies
- CAPA management in collaboration with quality department
- Safety lead for designated products
- Chair of Safety Management Team for designated products
- Member of Clinical Project Team and Study teams as safety SME
- Input into, review and approve
- Clinical development strategy
- Study protocols
- Clinical Study Reports
- Aggregate reports such as DSURs
- Investigator brochures
- Lead escalation to senior management / Safety Review Committee
Person Specification
- Life Science / Nursing or Pharmacy Degree
- Both safety science and case operations experience
- Extensive experience in Pharmacovigilance (PV). Previous experience of working in a managerial level role within PV
- Full understanding of the role of PV; Strong technical PV knowledge including protocol design, aggregate reports, signal detection and risk evaluation
- A willingness to be hands on when needed, but the ability to provide higher level
guidance
Highly Desirable
- Oligonucleotides experience or relevant drug development of novel therapies
- Cardiology or hematology expertise
- Primary degree in molecular biology or biochemistry
- Desire and ability to propose, implement and demonstrate the value of new methods and approaches;
- Commitment to using your skills for translational research to develop safe effective new medicines;
- Engender a performance culture within R&D that develops and delivers high quality, innovative outcomes and solutions on time to drive company growth; and
- Holds a passion for collaborative working and building relationships, with a clear affiliation to our vision and values, and a desire to become a true ambassador for our organisation.
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