Investigational Medicinal Product Manager*
Here, you’ll achieve greatness.At BioNtech, you will set up complex structures to ensure efficient and timely supply of our clinical studies with test medication in an innovative international environment in compliance with regualtory requirements. Thereby you make an indispensable contribution to the planning and operational interface between Clinical Operations, Program Management, Quality Assurance and GMP Manufacturing 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, support in set up and maintenanace of IRT systems (Interactive Response Technology)
- 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
- Knowledge in implementation & maintenance of IRT systems would be a plus
- 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. Willing and ready to take over responsibility
- Very sound knowledge and experience in relevant legislation and international GMP, GDP and GCP guidelines
- 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