Clinical Project Leader (100%)

Are you passionate about leading groundbreaking clinical research in the biotech industry? We have an exciting opportunity for a Clinical Project Leader at a clinical-stage company that achieved positive Phase II results this year and FDA fast track designation for their trials.Join a dedicated team developing innovative vaccines against multiple bacterial infections. As a Clinical Project Manager, you will play a crucial role in driving the success of the clinical trials, ensuring that the projects are completed on time, within budget, and to the highest quality standards. As the Leader, you will be managing part of the clinical team. 

3 days office presence in Zurich. Rest remote.

Responsibilities

• Develop and implement clinical development plans and regulatory strategies to achieve successful outcomes.
• Proactively assess risks and propose solutions to ensure smooth clinical operations.
• Manage and lead the clinical team, ensuring efficient use of resources and adherence to scope, quality, budget, and timelines
• Select and oversee external vendors, including CROs, clinical sites, and laboratories.
• Oversee the preparation and review of clinical study documentation.
• Ensure compliance with ICH GCP (E6-R2) guidelines, local regulations, and company-specific SOPs.
• Ensure timely submissions to Ethical Committees and Regulatory Authorities.

Qualifications:

• PhD, PharmD or Medical Degree is a must.
• Minimum 5 years of experience in clinical research and development. Hands on operational experience.
• Proven leadership and team/project management skills within a clinical setting. Or someone ready to take on a leading function as their next step.
• Strong understanding of ICH GCP guidelines and local regulatory requirements.