Investigational Medicinal Product Manager*

  • Mainz
  • Junior, Career start
  • Work experience
  • Project Management, Product Management
  • Transport
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Become a member of the BioNTech Family!

As a part of our team of more than 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age: Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project “Lightspeed” based on our mRNA-technologies. Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.
 
We aim to achieve life-changing successes for patients by being innovative, passionate and united,so get in touch with us if you are looking to be a part of creating hope for a healthy future in many people´s lives.

Investigational Medicinal Product Manager*

At BioNTech, you will set up complex structures to ensure efficient and timely end-to-end supply of our clinical studies with investigational medicinal products in an innovative international environment in compliance with regulatory requirements. Thereby you make an indispensable contribution to the planning and operational interface between Clinical Operations, R&D Program Management, Quality Assurance and GMP Manufacturing of clinical trial materials. Your main responsibilities are:
  • Accountable for management, coordination and efficient on-time delivery of study medication, supply for global Phase I-IV clinical trials to enable the fulfillment of company milestone. This includes demand forecasting, resupply planning, label design, packaging, distribution, destruction, drug accountability and active contribution to clinical core documents
  • Collaborate to develop strategic global plans with various departments to ensure optimal drug supply, considering availability of drugs, expiry dating, production slots, import and export requirements and patient activity for all sites in clinical trials/Program and in line with changing needs
  • Ensures compliance with SOPs, GMP, GDP and GCP regulations of activities and documentation for clinical trial supply. Participates in and supports internal/external inspections and audits
  • Accountable to perform IMP-related risk assessments for allocated clinical trials and to ensure traceability of all trial-related medication over the duration of the clinical trial. Assists in or leads risk evaluation processes and the conduction of complaint recall events to ensure patient safety
  • Initiation, set-up and conclusion of supply contracts. Provide and track external costs for budgeting purposes for study medication, external CMO packaging/labelling/distribution services and manage respective inventories as required. Responsible for vendor surveillance & performance management, on-time completion of outsourced tasks/activities for allocated global clinical trials Phase I to IV

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 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
  • Business-professional English language skills are mandatory, good German language skills are advantageous

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

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, Vanessa Hauk 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

https://biontech.de