What are the responsibilities and job description for the Associate Director CTSM IMPM position at BioNTech SE?
Cambridge, US | full time | Job ID: 9862
Lead Global Clinical Supply Strategies That Make a Difference. Orchestrate portfolio-level supply strategies for global clinical trials, ensuring patients receive the therapies they need—on time and without compromise. Define and lead initiatives of all Clinical Trial Supply Management IMPM-Portfolio activities in global Phase I-III clinical trials (R&D Programs).
Key Responsibilities:
What we do with the BioNTainers:
We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA-manufacturing facilities based on a container solution called “BioNTainers”. Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional end-to-end mRNA manufacturing solutions.
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.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.
Lead Global Clinical Supply Strategies That Make a Difference. Orchestrate portfolio-level supply strategies for global clinical trials, ensuring patients receive the therapies they need—on time and without compromise. Define and lead initiatives of all Clinical Trial Supply Management IMPM-Portfolio activities in global Phase I-III clinical trials (R&D Programs).
Key Responsibilities:
- Define and lead initiatives for CTSM portfolio activities, ensuring alignment with platform portfolio strategies and clinical trial requirements.
- Develop and oversee distribution, manufacturing, and supply planning strategies for platform portfolios.
- Manage performance objectives and performance management for trials within the platform portfolio.
- Ensure platform portfolio requirements are followed across all related clinical trials.
- Oversee planning activities at the platform portfolio level, orchestrating the needle-to-needle supply process.
- Liaise with interfaces to address trial escalations and prioritizations.
- Provide CTSM feasibility perspectives to platform portfolio core teams.
- Provide guidance to Managers IMPM during trial setup, execution, and closeout phases.
- Train new team members to follow SOPs and ensure adherence to IMPM standards.
- Ensure compliance with GCP and GMP principles, as well as Quality Management Systems.
- Coordinate and compile regulatory documents, ensuring accuracy and consistency.
- Build and maintain strong relationships with internal and external stakeholders, ensuring alignment and effective communication.
- A relevant university degree in Pharmacy, Chemistry, Biotechnology, Biochemistry, or a related discipline. Doctorate preferred, if applicable.
- At least 5 years of experience in Clinical Trial Supply Management within the pharmaceutical or biotech industry.
- Proven track record in managing multiple trial platforms and portfolios, as well as developing platform portfolio strategies for clinical trials.
- Background in Project Management and Operations is preferable.
- Deep knowledge of GCP and GMP principles, including SOPs, documentation, and ethical standards.
- Proficiency in IRT systems and standard office software (e.g., MS Office).
- Extensive knowledge of performance management in IMPM and Quality Management Systems.
- Ability to lead individuals with diverse professional backgrounds and expertise levels.
- Strong decision-making skills, strategic thinking, and negotiation abilities.
- Business-professional English language proficiency.
What we do with the BioNTainers:
We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA-manufacturing facilities based on a container solution called “BioNTainers”. Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional end-to-end mRNA manufacturing solutions.
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.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.
