BrightOwl Loader Loading

(Senior) Director Clinical Supplies & Logistics - Netherlands  

Company managed [?] Still accepting applications
79 Facebook  Linkedin

Posted on : 16 April 2017

Project Description

  • Our company  is a clinical-stage biotech company that is focused on the development of game changing RNA based therapies for severe genetic diseases. 
  • Our HR department is currently looking for someone that is talented and highly motivated that can strengthen our team. You will report to the Director HR 

What we offer!
  • We offer an exciting and innovative working environment within a very committed start-up organization, great colleagues and a lot of fun! 
  • We believe in our strong culture; personal responsibility, flexible workhours and places. Off course we pay a good salary.
  • You will have a training budget and we will pay your pension and you will get travel allowance. 
  • Do you think you can contribute in achieving our mission AND
  • Do you want to work in challenging environment where your work can really make a difference?
  • We are looking for a (Senior) Director Clinical Supplies & Logistics

What are you going to do: 
  • The Manufacturing & Pharmaceutics Department is looking for a professional with demonstrated ability to develop and drive our (Clinical) Supply Chain strategy. 
  • The successful candidate will be a highly skilled professional in the field of drug supply from early development up to commercialization.
  •  In addition, the successful candidate will be a great communicator with demonstrated success building strategic relationships with internal as well as external (CMOs, distributors etc.) stakeholders.
  • The (Sr) Director Clinical Supplies & Logistics is responsible for all aspects of the Supply of company's Oligonucleotide Drug Products, developed for (ultra)orphan indications.
  •  These responsibilities include:
    •  global short- and long term supply strategy,
    • vendor management,
    • operational aspects related to end product supply, 
    • adherence to GxP requirements related to drug supply.  

Major Accountabilities
  • Enable delivery of Clinical Drug Products to be tested in clinical trials, meeting Quality and Project Planning requirements. 
  • Oversee Clinical Supply Chain globally including operational oversight of manufacturing, packaging and labeling activities. 
  • Oversee technology transfer, process qualification, scale up and process validation activities at CMOs. 
  • Provide technical support to manufacturing operations as required. 
  • Drive & maintain company’s Clinical Supply Chain. 
  • Create and implement long term Supply Chain strategy.  
  • Stakeholder (CMOs, distributors etc.) management. 
  • Manage all financial and contractual aspects of assigned projects, including vendor negotiations 

We ask
  • Advanced degree (PhD/Engineer; or appropriate Master’s level) required.10-15 yrs of prior experience in managing a global, complex (Clinical) Supply Chain organization in Pharma/Biotech Industry. Proficient level of understanding of pharmaceutical business, including drug development process, and legal/compliance global environment. 
  • Proven ability to successfully operate a Clinical Supply Chain predominantly based on outsourced capabilities, especially the management of CMOs is critical. 
  • Strong ability to collaborate and build strategic relationships with internal as well as external (CMOs, distributors, etc.) stakeholders.  
  • Successful experience in launching new drug products globally. 
  • Experience with demand planning and forecasting to improve inventory management while appropriately managing risk. 
  • Ability to think strategically and take a proactive approach to problem-solving to complete projects according to predetermined timelines and react efficiently to changing priorities 
  • Must be well organized and able to multi-task in a fast-paced deadline driven environment 
  • Prior on-the-ground experience in (contract) manufacturing (managed a manufacturing plant as an example) is highly desirable. 
  • Ability to build, convincingly communicate and execute strategic and operational plans. 
  • Should enjoy challenging situations and have the flexibility to work in a dynamic and fast-moving environment where there is freedom to act.