Job Description
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Provides clinical and scientific expertise to support effective and efficient siRNA product development, including translation of non-clinical programmes through clinical development and contributes to Silence Therapeutics strategic programme Integrated Development Plans (IDP).
Role Overview
This role will drive the design of clinical trials, development of protocols, and other study and regulatory-related documents for several programs, in liaison with other functional leads. This role is within the Clinical Science department and the appointee will be a member of the Core Project Team and Clinical Science – Regulatory Strategy team.
Key Responsibilities
- Provide clinical and scientific expertise to the design of studies, writing of protocols synopsis, and other study documents across programmes.
- Leads the Clinical Sub Teams for relevant assets
- Key member of the Clinical Science-Regulatory strategy team
- Collaborates with external partners and stakeholders, such as clinical investigators, clinicians, scientists, key opinion leaders (KOLs) and Patient Advocacy Groups (PAGs)
- In conjunction with other relevant functional areas, provide clinical science leadership to guide the Integrated Development Plan (IDP) and Lifecycle Plans (LCPs)
- Participate in the analysis and interpretation of data, assist in reporting of study results including preparation of scientific summaries, abstracts and manuscripts
- Works with regulatory and other internal and external partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation
- Translational scientific liaison between clinical team and drug discovery and molecular design for assigned programmes, contributing to target selection activities.
- Ensures compliance with SOPs, ICH, GCP and other national and international regulatory requirements
Person Specification
The Senior Director, Clinical Science will be able to demonstrate the following competencies and behaviours:
- Extensive clinical experience in therapeutic areas relevant to Silence Therapeutics existing (Haematology/Cardiovascular) and emerging clinical siRNA programmes.
- MD or PhD in relevant biological sciences discipline, translational medicine or similar area. Haematology training/expertise is highly desirable.
- Industry experience of drug discovery and development.
- Credible track record of lead/senior authorship on high impact and/or translationally relevant publications.
- Demonstrable track record of leading cross functional clinical development teams and delivering results.
- Holds a passion for collaborative working, building relationships and excellent stakeholder management experience
- Has a desire to broaden their experiences beyond clinical science and engage with wider project matters that add value to our growing organisation
- Clear affiliation with our vision and values, and a true ambassador of our organisation
- Proactive self-starter with a hunger to apply their knowledge in a rapidly evolving field
United Kingdom
72 Hammersmith Rd.
London, W14 8TH
+44 (0)20 3457 6900
Germany
Robert-Rossle-Str. 10
D-13125 Berlin
Germany
+49 30 9489 2800