An exciting opportunity has arisen for a Senior Clinical Operations professional with a background in small Biotech environments, to join a highly ambitious and pioneering business based on Induced Pluripotent Stem Cells (iPSC). We are recruiting for a Director / Associate Director of Clinical Operations, ideally with some cell therapy experience. The company will consider someone either stepping up into this role or someone who is well-established at Director / Head level.
You can be based from home, ideally in the UK but potentially in Western Europe, and you will have significant autonomy in the organisation of early phase clinical trial design, setup and management. The company is offering an outstanding salary and benefits package(including seed options) and this will be a highly rewarding position with lots of potential for ongoing personal development.
The Role
Reporting to the CMO, you will play a central role in the development and translation of pluripotent stem cell-derived products by applying in-depth technical expertise to a range of process and analytical development activities. You will work closely with scientists at a partner university and will interact with several other collaborators.
Your role will have a broad remit, including:
Setting and implementing Clinical strategy
Project management
Vendor management, including contract negotiation and auditing
Financial accountability
Engagement with Research Ethics Committees and Regulatory authorities
Establishing links with Patient Advisory and Advocacy Groups and delivering Public Patient Engagement strategy
Full details will be provided on request. The company is entering an initial UK-based Phase I study (up to 30 participants), based in the UK, and has significant funding and ambition to build on this clinical proof of concept trial.
Skills and Experience Required
PhD or Scientific degree with equivalent experience, preferably with several years’ senior clinical operations experience with some early-stage therapeutic development
Strong project management skills
Track record of early phase clinical trial design/setup/management ideally with exposure to cell therapies
Fully conversant with regulatory requirements and ICH GCP
Hands on experience of clinical trial operations, experience as a Clinical Trial Manager or CRA
Experience of preparation, and submission, of regulatory, ethics and clinical manuals and dossiers
Excellent communication skills, demonstrating an ability to communicate on all levels within a multidisciplinary team
Awareness of the opportunities and challenges that come working for a biotech company, and a willingness to embrace change and get stuck in.