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Senior Manager, Clinical Supply Chain

Waltham, MA

Senior Manager, Clinical Supply Chain

Reporting to the Senior Director of Clinical Supply Chain, the Clinical Supply Chain Senior Manager is responsible for the management and oversight of end-to-end clinical supply chain activity for assigned clinical protocols. This position works closely with key stake holders including Clinical Operations, CMC, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure seamless supply of Clinical Trial Material. Some key areas of management/oversight include forecasting, packaging, labeling, distribution, inventory management, financial planning/ budgeting, and vendor oversight.

Responsibilities (including, but not limited to):

  • Manage end-to-end clinical supply chain activity across assigned protocols including forecasting, packaging, labeling, distribution, inventory management, and destruction for global clinical trials
  • Ensure on time delivery of clinical trial material to clinical sites while maintaining cost-effectiveness and compliance with regulatory requirements
  • Drive label creation and approval process, including translations and regulatory requirements
  • Partner with Clinical Operations to align clinical supply needs and timelines
  • Develop supply strategies to maximize supply efficiency and minimize waste
  • Design and actively manage supply & demand forecasts in our home-grown optimization tool
  • Monitor enrollment activity and inventory levels at depots and sites through the life of the trial
  • Identify potential supply risks, and develop risk mitigation plans as necessary
  • Support Interactive Response Technology (IRT) development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material
  • Support return and destruction of clinical trial material for assigned protocols
  • Prepare and manage budget for assigned protocols utilizing budget, planning, and allocation tools
  • Communicate clinical supply requirements to CMC and ensure seamless coordination of demand and supply
  • Oversee third party vendors for assigned protocols to ensure alignment and delivery on project requirements and ensure service levels, quality, and timelines meet Dragonfly standards
  • Review clinical documents to ensure alignment with clinical supply chain activity
  • Provide support for regulatory filings as needed (IND, CTA, IMPD updates, etc)
  • Ensure adherence to applicable regulations including FDA, EMA, ICH, GMP, GxP, and Dragonfly policies and procedures

Education / Skills / Experience Required:

  • Bachelor’s degree in Life Sciences or Supply Chain Management
  • 5+ years clinical supply chain experience
  • Strong understanding of end-to-end clinical supply chain activity
  • Experience with supply/demand forecasting
  • Experience with IxRS/ IRT/ RTSM system set-up and management
  • Strong understanding of GxP
  • Demonstrated ability to adapt to change through identifying new strategies and tactics
  • Strong attention to detail
  • Excellent communication, collaboration, and influencing skills
  • Ability to multi-task and manage complex challenges
  • Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc

Skyhawk Therapeutics is committed to pay transparency and equitable compensation practices. The base salary range for the Clinical Program Manager is $120,000-160,000 annually. This range reflects the minimum and maximum target for such position. Skyhawk Therapeutics will assess the appropriate level for a qualified candidate based on job-related skills, professional experience, and relevant education or training.

 

About Skyhawk

Skyhawk is committed to discovering, developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets.

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