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Career Openings


Clinical Supplies Manager

ID: 1411
Department: CMC Pharmaceutical Dev
Location: Cambridge Headquarters
# of Openings: 1

Description

Functional area: CMC Management, Pharmaceutical Development

 

Position Description:

This position offers the opportunity to lead the Clinical Supply function for a robust clinical development pipeline supported by sustainable company financial growth and a thriving, flexible work culture. Today, we have treated over one million patients with LINZESS®, our first commercial product for irritable bowel syndrome and chronic idiopathic constipation, and recently launched ZURAMPIC® and DUZALLO® for the treatment of gout.  Our diverse pipeline includes innovative treatments for gastrointestinal, vascular and fibrotic diseases that address areas of high unmet medical needs.

 

We are seeking a customer-oriented, highly collaborative individual to lead the packaging, labeling and distribution of investigational product and serve as a key connection point between Pharmaceutical Development and Clinical Operations.  The ideal candidate will be able to engage and establish effective working relationships with internal stakeholders across multiple departments including Formulation Development, Analytical Development, Clinical Operations, Regulatory Affairs, and Quality Assurance.      

 

 

Responsibilities:

  • Design and execute packaging and labeling campaigns:
    • Translate clinical protocol information into demand forecasts and supply strategies
    • Develop campaign timelines and budgets
    • Develop IRT supply specifications and clinical label texts
    • Manage CMOs to deliver study material on time\ budget
    • Manage IP distribution through study closeout and drug destruction
  • Lead process improvement initiatives and author\ revise clinical supply SOPs
  • Manage relationships with packaging and labeling CMOs and track vendor performance
  • Serve as primary interviewee in regulatory inspections\ audits as needed

 

Qualifications:

  • Bachelor degree in scientific discipline with 3+ years of relevant clinical supply chain experience
  • Excellent communication, interpersonal, and follow-through skills with strong attention to detail
  • Solid understanding of cGMPs and the clinical research process
  • Experience managing contract packaging and labeling organizations (strongly preferred)
  • Experience with IRT systems and ex-US clinical supplies management (considered a plus)


Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.





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