Investigational Medicinal Product Manager*
Here, you’ll achieve greatness.At BioNtech, you will soon be working on new structures for the efficient and timely supply of our clinical studies with test medication. Thereby you make an indispensable contribution to the planning and operational interface between clinical research, project management and GMP production of clinical trial samples. Your duties in detail:
- Lead and conduct clinical program associated with Investigational Medicinal Product Management (IMPM) activities, such as but not limited to demand planning, definition of supply strategy, set up of clinical supply chain, set up of IRT
- Monitoring and analyzing project performance to anticipate obstacles and resolve issues in cooperation with supporting functions to ensure project milestones are met, continuous improvement by identifying opportunities
- Lead the development and establishment of an agreed storage, labelling and packaging specification, supply & distribution strategy under full GxP compliance, consecutively from study start to completion, including returns, destruction and traceability of IMPs and all trials
- Establishing, optimization, standardization and harmonization of IMPM processes and documentation across multiple clinical trials with very high complexity
- Representing IMPM team in internal and external project and study teams, organize and facilitate meetings
What you have to offer.
- Professional experience in the pharmaceutical industry or biotechnology and proven track record of clinical supply chain, logistics set up & management, and implementation & maintenance of IRT systems in global clinical trials up to Phase III
- Proven track record of Clinical PM experience in pharmaceutical or biotech industry
- Able to rapidly enter in action and to work under stress conditions in a versatile environment, highest degree of resilience and flexibility
- Very sound knowledge and experience in relevant legislation and international GMP, GDP and GCP guidelines. Willing and ready to take over responsibility
- Effective stakeholder management, both in cross-functional internal and external matrix team environment
- Excellent organization and communication skills as well as highly motivated and open-minded team player, enjoys working in a team and is able to motivate a team
- Very good English language skills are mandantory, good German language skills are advantagoeus
Benefits for you.
Have we kindled your pioneering spirit?Then apply now for our location Mainz and simply send us your application documents using our online form.
If you have any further questions, Friederike Mangelsen will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
BioNTech - As unique as you