Career Details

Summary

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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