Associate Director* CTSM IMPM
Open for hire at one of the following locations – London, Gaithersburg, Mainz Goldgrube. - Job ID: 7370
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. 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.
Associate Director* CTSM IMPM
At BioNTech, you will set up complex structures to ensure efficient and timely end-to-end supply of our clinical trials with investigational medicinal products in an innovative international environment in compliance with regulatory requirements. You will 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:
- Liaise with interfaces when trial escalations and trial prioritizations are needed
- Provide perspective on CTSM feasibility into platform portfolio core team
- Translate platform portfolio strategy into platform portfolio trial requirements
- Design and structure initiatives based on platform portfolio strategy
- Design distribution / manufacturing / supply planning strategy per platform portfolio and oversee needle-to-needle supply process
- Define and implement performance objectives for trials platform portfolio
- Manage performance management for trials in platform portfolio
- Oversee the planning activities on platform portfolio level across all related clinical trials in platform portfolio
- Ensure platform portfolio requirements are followed in trials
- Accountable for execution of assigned clinical platform / programs
- Ensures IMPM SOPs are followed
What you have to offer.
- Relevant completed university education in Pharmacy, Chemistry, Biotechnology, Biochemistry, or related discipline
- Relevant professional experience (usually +5 years) in Clinical Trial Supply Management in Pharmaceutical or Biotech industry setting Background in Project Management and Operations preferable
- Proven track record in developing platform portfolio strategy for clinical trials
- Deep Knowledge of GCP Principles (e.g., Ethical Principles, Adequate Drug Information, etc.) as well as deep knowledge of GMP Principles (SOPs, Documentation, etc.)
- Deep Knowledge about IRT systems and standard office software proficiency (e.g., MS Office)
- Excellence project management skills as well as stakeholder management skills
- Extensive Knowledge about performance management in IMP
- Good understanding of Quality Management Systems
- Experience in compilation and coordination of regulatory documents
- Ability to lead various individuals of different professional backgrounds and expertise levels, with resilience to constantly changing work environment
- Business-professional English Language skills
Benefits for you
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Click here to find out more about what we do, the careers we offer ans also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – London, Gaithersburg, Mainz Goldgrube. Apply now for your preferred job and location through our careers site.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!