Immunic AG is a NASDAQ-listed, well-financed and dynamic biotechnology company located in Gräfelfing near Munich. We are a specialist in selective oral drugs in immunology and focused on developing novel oral therapies with best-in-class potential for chronic inflammatory and autoimmune diseases.
Currently, we have three drug candidates in different stages of clinical development. More information can be found at http://www.imux.com.
We are a team of ambitious people with different background that love to work together. Immunic is an exciting place for fresh ideas – apply now and become part of our team!
We are looking for a
(Senior) Clinical Project Manager (m/f/x) (PT or FT)
for an unlimited part-time (at least 80% required) or full-time position in order to reinforce our Gräfelfing/Munich based team.
Immunic is looking for a project leader for the operational execution of a phase 3 development. Ideally, we are looking for a candidate who can oversee, direct and lead all project-related clinical operations activities for this project. The Clinical Project Leader works directly with the Head of Clinical Operations and the Chief Medical Officer of Immunic AG.
We anticipate a broad scope of activities:
- Leading the preparation of a Phase 3 trial in Multiple Sclerosis in collaboration with a CRO (protocol development, performing site/country qualifications, and regulatory submissions), medical consultants and experts, and with regulatory consultants
- Act as overall clinical project manager for this study in all aspects, including
- Providing sponsor oversight of all activities
- Vendor qualifications
- Selection of and interaction with service providers, including being the primary contact of the company for these service providers, and perform vendor qualification
- Oversee start-up activities of trial
- Review study data entry on ongoing basis and make recommendations for further activities to achieve goals
- Oversee the project budget
- Participate in the ongoing preparation of End-of-Phase 2 meetings
- Participate in CRO selection and bid-defense activities
- Interacting with medical experts and the Steering Committee
Should require at least 80% of FTE of full-time
- Last, but not least you will work closely with the Immunic management team to provide reporting of execution of Phase 3 goals and timelines.
Here is how to convince us:
- Our team is small, and you enjoy working in a dynamic work environment of an entrepreneurial company.
- You are open-minded, and you strive to find the best solutions in a team environment.
- You are able to self-structure your work and drive processes, have good project management skills, and are willing to take responsibility and make decisions.
- You are used to work on your own initiative but with high team spirit and the ability to network within the team.
- You are happy to work in a flat hierarchy environment and have a hands-on mentality.
- You have a good cultural fit to the current team of Immunic AG.
- You are fluent in English with the ability to communicate accurately and effectively in verbal and written form (German language skills are optional).
- You have experience in the clinical development of pharmaceuticals, including experience in a pharma or biotech company or CRO.
- You have been involved in phase 2 or phase 3 clinical trials in different medical indications.
- You have been involved in regulatory submissions or start-up activities.
Please send your meaningful application specifying your salary expectations as well as the earliest possible starting date by email to email@example.com or by post to Immunic AG, Erika von der Decken, Lochhamer Schlag 21,
82166 Gräfelfing, Germany.