Clinical Delivery Leader
Functieomschrijving
We are looking for an experienced Clinical Delivery Leader to strengthen our team, reporting to the Head Clinical Operations. In this senior position, you will play a key role in overseeing and managing the delivery of clinical trials and programs across Agomab's clinical portfolio. You will lead cross-functional teams to ensure clinical programs are executed with precision, within timelines, and in compliance with regulatory standards. The ideal candidate will be a strategic thinker with strong leadership skills, excellent project management abilities, and a deep understanding of clinical trial operations. What will you do?
- Lead and manage the end-to-end delivery of clinical programs, ensuring they are conducted on time, within scope, and budget;
- Define the clinical operations strategy and oversee the operational aspects of multiple clinical trials, including study planning, execution, data collection, and reporting;
- Collaborate with cross-functional teams including data management, statistics, CMC, regulatory, quality, and external vendors to ensure efficient and high-quality program delivery;
- Develop and maintain clinical development plans, risk management plans, and mitigation strategies to address potential challenges;
- Ensure compliance with regulatory and ethical standards in clinical trials, including GCP, ICH guidelines, and applicable regional laws;
- Act as the primary point of contact for internal and external stakeholders for clinical program updates, timelines, and key deliverables;
- Drive continuous improvement initiatives in clinical operations processes and delivery practices;
- Support the development, design and optimization of clinical study documents, including study protocols, site guidelines, laboratory manuals, biomarker plan and other relevant clinical study documents;
- Support budget management, vendor selection, and contract negotiations as needed;
- Report regularly to senior management on clinical program status, key milestones, risks, and metrics;
- Act as Clinical representative in Project Teams and Clinical Development Teams.
Profiel
Who are you?
- You have a Master, PharmD, PhD or MD degree in the scientific, medical or paramedical area;
- You have ideally 10+ years of experience at a biotech or pharmaceutical company. Experience in early development is considered a plus;
- You have experience in driving clinical operations strategies within the regulatory clinical development landscape;
- You have a strong attention to detail and an expert in navigating scientific literature, interpretation of clinical data and display of clinical data;
- You have in-depth knowledge of ICH-GCP, clinical study designs and applicable regulatory guidelines;
- You have a sound experience using Microsoft applications (Excel, Word, PowerPoint, Outlook);
- You are an excellent team player with strong oral and written communications skills;
- Your project management skills allow you to identify and adapt to shifting priorities and competing demands while having the ability to maintain composure in difficult circumstances;
- You speak and write English fluently. Additional languages are a plus;
- You are most of all a motivated and self-driven person, independently managing your time and projects;
- You have experience in team management. Prior line management responsibilities are a plus.
Aanbod
What we offer
- The opportunity to develop pioneering science in a young biotech company;
- Challenging and innovative work environment as part of a driven team;
- Flexibility and responsibility based in Antwerp or Barcelona with remote working options that can be tailored for you;
- Competitive salary and benefits;
- An agile and fast paced environment.
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