My client is a clinical-stage biotech company located in mainland Europe with a focus on developing cutting-edge cell therapies in the field of regenerative medicine. The program is in Phase II.

The following responsibilities will include:

• Develop the clinical development strategy for their leading indication
• Manage the preparation and meetings with regulatory agencies, such as the FDA and EMA
• Oversee an advisory board to review and support our overall strategy
• Develop the preclinical and early-stage clinical development strategy for ischemic stroke and other future indications
• Supervise Drug Safety and Pharmacovigilance activities of Phase II, including managing the CRO to ensure comprehensive signal detection, monitoring, and safety information evaluation.
• Manage budgets and planning
• Support investor presentations

To be successful in this role, we are seeking candidates with the following qualifications:

• Medical Doctor (MD) with practical experience as a physician
• Minimum of 10 years of experience in clinical development (Phase 1 to 3) within the biotech and/or pharmaceutical industry
• Strong knowledge in cardiology
• Expertise in GCP and a solid understanding of the regulatory environment.
• Experience interacting with Key Opinion Leaders (KOLs) and health authorities
• Previous experience overseeing clinical safety
• Experience in biotechnology companies and/or start-ups is a plus
• MUST BE OPEN TO HYBRID WORKING