BioNTech IMFS
Associate Director, Clinical Trial Supply Management IMPM
Cambridge, US; London, United Kingdom | 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).
Your Contribution:
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 good match:
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.
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.
BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!
#J-18808-Ljbffr
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).
Your Contribution:
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 good match:
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.
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.
BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!
#J-18808-Ljbffr