Our 20-plus years of RNAi experience together with our validated mRNAi GOLD™ platform make us a partner of choice for pharmaceutical companies looking to access the benefits of the siRNA and add this revolutionary modality to their discovery pipeline. As pioneers in the design and development of siRNAs (short interfering RNAs), Silence Therapeutics is advancing a new generation of medicines to potentially address the needs of patients who have limited or inadequate treatment options.
Our mission is to use our technology to create a new generation of therapeutics that can improve patient outcomes and, in the process, build shareholder value.
We are developing a deep pipeline of innovative siRNAs based on our mRNAi GOLD™ platform for diseases with a genetic basis. The depth and versatility of our liver-targeting technology gives us the opportunity to address a wide range of conditions in virtually any therapeutic area. Our wholly-owned pipeline is currently focused in three therapeutic areas of high unmet need: hematology, cardiovascular, and rare diseases.
Role Purpose
The Senior Director, Clinical Science will provide clinical and scientific expertise to support effective and efficient product development, including translation of non-clinical programmes through clinical development and contributes to Silence product strategic Lifecycle Plans (LCPs).
Key Responsibilities
- Provide clinical and scientific expertise to the design of clinical studies, writing of protocols, and other study documents for programmes in different therapeutic areas.
- Integral member of phase 3 clinical development team for divesiran (siRNA program in Polycythemia Vera).
- Provide medical leadership to the divesiran program and act as Lead Silence Medical Monitor for phase 3.
- Leads and/or otherwise participates in assigned Clinical sub-team and relevant sub-team meetings, other interactions and communications.
- Support medical monitoring activities across the Silence platform as needed.
- Participate in the analysis and interpretation of data, ensure integrity of trial data, and assist in reporting of study results including preparation of scientific summaries, abstracts and manuscripts.
- Participates in regulatory interactions with global agencies (FDA/EMA) and contributes to strategic position of Silence’s assets.
- Collaborate 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, develop and provide clinical science information for inclusion into the Integrated Development Plan (IDP) and Lifecycle Plans (LCPs)
- 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
- MD with at least 5-7 years of drug discovery/development experience at pharma or CRO
- Clinical experience in therapeutic areas relevant to Silence Therapeutics existing and emerging clinical programmes.
- Experience as a medical monitor in randomized clinical trials
- Track record of designing and contributing to clinical studies working collaboratively with Clinical Operations to deliver results.
- Experience in leading /contributing to regulatory interactions with FDA/EMA
- 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.
- Proven ability to effectively prioritise workload and strong organisational skills.
- Strong attention to detail and pride in the quality of their work.
- Excellent written and verbal communication skills.
- Holds a passion for collaborative working, building relationships and excellent stakeholder management experience.
NOTE:This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the on-going needs of the organisation.
Silence Therapeutics is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.