Joshua Leggett is closely partnered with a fresh biotech headquartered in the Netherlands. This blossoming company has recently celebrated its 5th birthday by signing a huge collaboration with a globally known pharma company. Their company of 30 will take this €150 million agreement to continue conquering the Auto-Immune and T-Cell therapy space.
The client is in search of a Global Clinical Operations Manager. This is an Associate Director/Director level position and the selected candidate will report directly to the Vice President of Clinical. The appointed candidate will be responsible to pioneer new and innovative ideas into this multimillion-dollar project. In addition to this, you will have the opportunity to work with some of the most well-known names in the T-Cell space.
- Prepares all required documents for clinical studies
- Negotiates all aspects of clinical performance study agreements.
- Proposes and negotiates budgets for clinical performance studies
- Collaborate closely with statistics to ensure relevant study designs
- Ensures site compliance with clinical performance study protocol and ICH/GCP Guidelines
- Actively participates as member of cross-functional project teams
- Participates in assessing performance data by cross-functional teams
- Reviews and presents clinical data
- Participating in the selection of CROs and external vendors
- Responsible for initiation, SSU and close out of the trials
- Working closely with the pharmacokinetics, data management, statistics, medical writing, regulatory affairs, clinical supplies, medical oversight
- You will act as the representative for all clinical operations throughout the company
- Must have over 10 years’ experience in clinical operations and managing CROs
- Auto immune and/or oncology clinical trial experience is highly preferable
- Small Biotech experience is strongly favoured
- Strong background with maintaining strong external relationships
- Additional 1, or more European language is advantageous
If you are interested in applying, please do so below.
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