Clinical Trial Manager

This is a unique opportunity to join our exciting and dedicated Vaccibody team, allowing you to gain knowledge from and contribute to clinical development activities in one of Norway’s leading Biotech companies! 

We are currently looking for an experienced Clinical Trial Manager to join our team. The ideal candidate will have a proven record of excellent clinical trial management skills and expertise, profound knowledge of GCP and regulatory procedures and guidelines, and experience with clinical trial submission activities to regulatory authorities and Ethics Committees. Moreover, experience within oncology and/or vaccines as well as experience with adaptive clinical trial designs is preferred. 

Job responsibilities

• Responsible for all phases and aspects of clinical trial conduct; planning, start up, execution, follow-up, timelines and budget
• Managing a cross-functional clinical trial team with shared objectives and deliverables for the assigned trial(s)
• Ensure that assigned clinical trials are conducted in compliance with GCP, relevant SOPs and regulatory requirements
• Ensuring that clinical trial deliverables meet the agreed quality levels and KPIs
• Responsible for CRO collaboration, oversight and adherence to scope of work within agreed timelines and budget
• Contribute in planning, design, writing and review clinical trial protocols, amendments and clinical study reports
• Update internal stakeholders on trial related milestones, risks and action plans
• Write input to and review clinical documentation created in collaboration with CRO or internal team members needed for submissions of CTAs/IND to Regulatory Authorities/ Ethics Committees
• Active contributor and key member in cross-functional project teams, responsible for all relevant clinical trial related contribution

Who are we looking for?

When hiring new employees, we look for the individuals who are inspired by Vaccibody’s entrepreneurial spirit and whom we think would be a good fit with our collaborative and inclusive company culture. We believe that you are driven by an eagerness to learn, you are proactive and not afraid of a challenge. You have a business-oriented mindset and your analytical thinking helps you excel in your field.

Education and experience requirements

• Master or PhD degree within medical, biological, pharmaceutical science or equivalent
• Minimum 5 years of experience in clinical research/clinical operations
• Experience from working in a global or regional organization within a pharmaceutical company, CRO or biotech company

Other qualifications

• You are flexible, have the ability to juggle several projects at once and enjoy working in several cross-functional team structures
• You have a talent for leadership, cross-functional team work and an ability to cooperate with multiple stakeholders
• You are an excellent communicator both in written and verbal form
• English fluency is required

Why join our Vaccibody Team?

Vaccibody is a clinical-stage biopharmaceutical company, founded in 2007. Since then, we have become one of the world’s most exciting Biotech companies, rapidly growing, today counting more than 40 amazing employees with medical and development teams, manufacturing, bioinformatics, and research teams. We are dedicated to the discovery and development of novel immunotherapies, and are using the Vaccibody technology to generate best-in-class therapeutics to treat cancers with a high unmet medical need. Furthermore, we also focus our research on infectious diseases. We closely collaborate with Roche and Nektar Therapeutics, and are proud to have entered into a worldwide license and collaboration agreement with Genentech, a member of the Roche Group, to develop individualized neoantigen cancer vaccines

At Vaccibody, we develop cutting-edge, targeted DNA vaccines for clinical use, based on a deep understanding of immunological principles. Vaccibody’s vaccines specifically target Antigen Presenting Cells. By intelligent design, Vaccibody’s vaccines can be tailored to induce the desired immune response profile correlating with protection for each specific disease with any given antigen. 

The people at Vaccibody are at the heart of our organisation, which is why we always keep striving to offer a workplace where they can have fun and find motivation. We provide our employees with opportunities for personal growth in close collaboration with our dedicated and experienced teams. Furthermore, we ensure that proper training is provided and support them in managing their work-life balance. Eager to learn more about our Team and our work? Please visit us at Vaccibody.com

Applications will be considered and reviewed after the deadline: November 29th. The role does not require a residency in Norway, however, travel is expected for this role.

We look forward to receive your application!