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Manager/Sr Manager Clinical Supply Chain
Avalyn Pharma
 
Job Location: Seattle, WA
Location: Seattle, Washington, 98101, United States
Posted: 2021-02-09
Position Title: Manager/Sr Manager Clinical Supply Chain
Company Name: Avalyn Pharma
Sector: Research
Job Type: Full-Time
Min Education: BA/BS/Undergraduate


The Manage/Senior Manager, Clinical Supply Chain will focus on ensuring continuous supply for Avalyn Pharma's drug products and devices in support of clinical trials. This position will work with Clinical, CMC and QA, as well as with Contract Research Organizations (CROs) to accomplish project objectives and ensure product integrity and regulatory compliance. This position will develop packaging and distribution plans for study drug and devices and manage clinical supplies documentation requirements. This position will monitor and track inventory levels, identify potential supply chain issues and provide feedback and recommendations to the appropriate resources regarding demand, expiry and resupply of products. The Manage/Senior Manager will participate as an active member of the team to plan and manage the clinical supply tasks required for phase 1 - 4 studies. To ensure that the highest level of services is provided, additional duties may be assigned, and evening, weekend and holiday work may be required.



Responsibilities and Duties:

  • Review clinical trial protocols and understand impact on supply
  • Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, etc.
  • Participate in cross-functional Project Team Meetings
  • Create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and/or programs; while considering proactive approaches to worldwide disruptions, such as pandemics or governmental changes (e.g. Brexit)
  • Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered in strategic decision-making; escalate highrisk situations as warranted
  • Monitor inventory levels at depots and clinical sites through the life of a trial; take preventive actions to avoid potential supply issues
  • Coordinate review of batch records and other release documentation for study drug and devices
  • Manage label development/approval process and packaging timelines
  • Oversee CRO's coordination of US and international distribution and logistics, including distribution requirements and temperature excursion process
  • Act as the unblinded contact for Avalyn Pharma on all blinded studies
  • Oversee return and replacement of malfunctioning devices to manufacturer for analysis
  • Participate in the development of IRT for each study
  • Participate in audits of packaging and labeling CROs, as needed
  • Develop and maintain applicable metrics regarding Clinical Supply Chain activities
  • Review current SOPs; identify and initiate new SOPs, as needed
  • Participate in the development of departmental timelines and budgets, as well as review and approval of relevant vendor invoices




Required Knowledge, Skills and Abilities:

  • Proven organizational skills with the ability to prioritize and work well in an environment with competing demands
  • Experience in and knowledge of industry regulations and requirements pertaining to clinical trials
  • Strong, interpersonal, motivation and negotiation skills with an ability to communicate effectively at all levels
  • Knowledge of ICH, GCP, Data Privacy and other applicable regulations and requirements in the pharmaceutical industry
  • Strong influence and relationship building ability
  • Ability to plan, organize and monitor activities according to priorities, established schedules and deadlines
  • Ability to adapt to small-company hands-on culture
  • Ability to work under pressure
  • Proficiency in Microsoft Office (Excel, Word, Project, PowerPoint) or relevant Project Management software



Qualifications:

  • Bachelor's degree in life sciences, supply chain management, engineering or business major
  • Certification in Supply Chain Management (APICS CIPM/CSCP) preferred
  • Proven experience in supply chain, project management and production planning in a medium to high volume environment
  • 4 - 8 years of pharmaceutical industry experience within clinical supply chain management (respiratory experience preferred)
  • Experience in CRO management, including labeling, packaging, and distribution in North America, Australia/New Zealand and Europe
  • Experience with IRT system and implementation
  • Knowledge of cGMPs and relevant FDA and EU Regulations
  • Familiarity with US, AU, NZ and EU regulatory agencies and their guidance
  • Demonstrated experience with multiple clinical trials



Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job:

  • While performing the duties of this job, the employee is regularly required to talk and/or hear. The employee is frequently required to sit, stand; use hands to finger, handle or feel; and reach with hands and arms.
  • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
  • Occasional day and overnight travel is required to attend training, conferences, meetings or visit vendors (up to 10%).




PI130191174





 
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