Associate Director, Clinical Trial Supply Management, IRT Systems


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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, Clinical Trial Supply Management, IRT Systems 

 

Responsibilities: 


Leadership Responsibilities
•    Manages IRT team members. Supports professional development
•    Leads IRT standardization efforts within BioNTech.
•    Collaborates with vendor management to develop Preferred Provider relationships with selected IRT vendors
•    Remains current on IRT vendor and capability landscape
•    Act as point of escalation for issue resolution for the internal study teams and/or IRT providers
•    Supports cross organizational initiatives which require IRT team support (e.g., Data Standardization Initiatives)
 

Study Support
•    Identifies study supply parameters with input from IMPM
•    Coordinates communication of study parameters to the IRT vendor
•    Coordinates IRT system setup and maintenance (User Requirement Specs review, User Acceptance Testing)
•    Prepares and reviews UAT test script
•    Coordinates UAT testing and identifies risks in configuration
•    Consolidates feedback and coordinate assessment of risks identified during testing
•    Uploads completed IRT User Requirement Specification and UAT testing to eTMF
•    Develops training material for IRT
•    Drives performance management with vendor (e.g., KPIs and debugging)
•    Key contact to IRT vendor
•    Supports and trains users on IRT system usage
 

Requirements:

•    Relevant professional experience (usually +7 years) with IRT systems in Clinical Trial in Pharmaceutical or Biotech or any other equivalent industry setting

•    Deep Knowledge about IRT system functions and best practices
•    Experience managing IRT teams (direct line management)
•    Firm knowledge of the IRT vendor landscape and capabilities
•    Prior experience in IRT Standardization efforts (development and maintenance)
•    Deep knowledge about IT-System Validation & compliance activities
•    Deep understanding of patient randomization strategies and potential impact on clinical supply wastage/optimization
•    Standard office software proficiency (e.g., MS Office)
•    Significant experience across multiple study designs/types in optimization of clinical supply chain, through use of IRT technology.
•    Working knowledge of clinical supply chain and associated GMP/GDP activities
•    Ability to read and understand clinical protocols and translate requirements for IRT system needs
•    Ability to develop training materials and conduct trainings
•    Business-professional English language skills

Preferred Skills:

•    Demonstrated people leadership abilities
•    Ability to solve multi-layered and dynamic activities 
•    Self-motivated with strong problem-solving and learning skills
•    Able to accurately work under pressure in a versatile environment
•    Willing and able to take over responsibility and ownership
•    Ability to create independent analyses and develop new solutions
•    Excellent organizational and communicative skills
•    Stakeholder management 
•    Liaises with other functions to have basic cross-functional understanding
•    Enjoys working in a team
•    Ability to coach, mentor, and collaborate with business partners, analysts, and team members
•    Strong work ethic: ability to work at an abstract level and gain consensus 
•    Openness to explore on new topics for setting up the trend

 


Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.


 

How to apply: 

Apply now and simply send 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 by using our online form.

Please note: 

  • Only applications sent via our online form shall be considered.
  • Only Candidates with the right qualifications and relevant experience shall be shortlisted and
  • Incomplete applications shall be rejected.
  • Please note that BioNTech will run a background check during the hiring process


We are looking forward receiving your application.


*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!

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