19 days old

Director, Supply Chain (Pharmaceuticals)

Avadel Management Corporation
Remote, Other
  • Job Code
    175538479

About Avadel Pharmaceuticals plc

Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate, FT218, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com. Our organization fosters our culture based on being relentless for patients, having confidence with humility, being courageous, taking insight to action and togetherness. Success for us is defined through how we improve the lives of patients and how we achieve our objectives as ONE Team.

Our approach to developing new medicines is based on applying proprietary, drug delivery technology that improves the way drugs are dosed and released. We are currently focused on the development and potential FDA approval of our lead candidate, FT218.

Avadels FT218 is an investigational, once at bedtime, extended-release formulation of sodium oxybate intended to treat excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. Sodium oxybate is currently the standard of care for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. However, currently approved sodium oxybate products are immediate release formulations requiring two nightly doses - one dose at bedtime and the second dose 2.5-4 hours later, in the middle of the night.

Once at bedtime FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that once at bedtime FT218 may be clinically superior to a formulation of sodium oxybate already approved by the FDA for the same indication. In particular, once at bedtime FT218 may be safer due to ramifications associated with the dosing regimen of the currently marketed twice-nightly product. Avadels market research suggests that FT218, if approved by the FDA, has the potential to command a meaningful share of the multi-billion-dollar narcolepsy treatment market. FT218 currently has patent protection until at least mid-2037 with additional patent applications pending that could extend that date beyond 2040.

On April 27, 2020, we announced positive topline results from our pivotal phase 3 REST-ON trial of once-nightly FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. On December 16, 2020, we announced the submission of our New Drug Application (NDA) in the United States for FT218. On March 1, 2021, we announced FDA acceptance of the FT218 NDA. Review and approval of the NDA is currently in process with the FDA.

We are a small, agile, and patient-obsessed team that is growing, and we have a lot of work to do in building our best-in-class team to support the launch and commercialization of FT218, if approved, and the future expansion of our portfolio. We are seeking bright people who want to roll up their sleeves, build our company together and make an impact so we can help people living with narcolepsy.

Position Summary:

The Director, Supply Chain will lead or direct all activities tied to material movement, shipping & logistics, supply/demand planning & analysis, operations process management, and other facets found within a supply chain operations department. The Director, Supply Chain will oversee all supply and customer service related Third-Party Logistic Provider activities as well as will work with various internal departments to support developing and implementing robust processes enabling a smooth and effective supply chain. This role provides functional leadership to the day-to-day operational activities of the department, complies with supply chain policies, best industry standards, and applicable regulations, as well as works in close collaboration with the External Manufacturing, Quality Assurance and Commercial teams.

Essential Functions:

  • Provide departmental oversight and leadership with a primary focus on:
    1. Vendor management of all contract manufacturing organizations, API / key material vendors, Third-Party Logistics Provider, and transportation partners
    2. Production planning and vendor level forecasting
    3. ERP/MRP
    4. Serialization
  • Have responsibility for inventory management for the business from forecasting to procurement to delivery (end-to-end delivery)
  • Works closely with Sales and Marketing team members to understand any communicated forecast changes to effectively evaluate and communicate the impact on supply.
  • Develop a comprehensive understanding of a newly implemented ERP/MRP software platform.
  • Serves as senior functional point of contact with vendors and carriers to maintain relationships and drive accountability for contractual metrics.
  • Manage all activities as it relates to Customer Service/ Third-Party Logistics Provider oversight and logistic support resolving any order issues; including arranging finished good shipments as product is released from manufacturer to 3PL.
  • Develop, roll out and lead a Sales and Operations Planning process to facilitate cross-functional review and approval of supply/demand plans and strategies.
  • Accountable for inventory levels at Contract Manufacturers and Third-Party Logistics Provider; take preventive actions to avoid potential supply issues while minimizing product loss to expiry or destruction.
  • Support all aspects of the Serialization program, including process management and governance as well as system setup and integration. Work with CMOs and third-party providers to ensure all compliance requirements are fully met.
  • Oversee State License requirements
  • Provide inputs for annual DEA quota requirements
  • Evaluate current processes and implement improvements that will benefit Supply Chain and assist with enhanced organization and efficiency.
  • Crafts functional strategies and specific objectives for the Supply Chain department and develops budgets/policies/procedures to support the company infrastructure.
  • Establish and report against departmental KPIs and metrics.
  • Support Finance initiatives as it relates to the monitoring of internal spend and purchase orders thresholds
  • May assist in developing and implementing software solutions
  • Performs other supply chain/purchasing/inventory control duties as assigned

Experience and Qualifications:

  • Bachelor's degree in Business, Supply Chain, or related field
  • Minimum 5 years of progressive experience in Pharmaceutical Supply Chain Management: Inventory Control, Logistics.
  • Minimum 3 years in a people management role.
  • Minimum 3 years ERP / MRP / system experience with Supply Chain, Inventory and Planning, preferably SAGE.
  • Familiarity with scheduling freight carriers, coordinating inbound deliveries.
  • Working knowledge of DEA Controlled Substances (CI, CIII in particular) and annual quota.
  • Working knowledge of Serialization.
  • Comfortable with Office 365 collaborative tool environment that is reliant on Microsoft Teams as well as Outlook, Excel, Word, PowerPoint, etc.
  • For the health and safety of our employees, customers, and community, vaccination against COVID-19 is required as a condition of employment for this position and you must provide valid proof of vaccination.
  • For the health and safety of our employees, customers, and community, vaccination against COVID-19 is required as a condition of employment for this position and you must provide valid proof of vaccination.

Other Competencies and Behaviors:

  • Outstanding organizational skills and ability to prioritize and reorganize workload to meet deadlines in a dynamic work environment.
  • Ability to manage multiple tasks and prioritize time sensitive situations in a fast-paced environment.
  • Excellent problem-solving skills and coordination abilities.
  • Strong communication and interpersonal skills
  • Ability to work with little supervision and track multiple processes
  • Demonstrate attention to details and follow through
  • Team player and can collaborate with others

Avadel is an Equal Opportunity Employer.





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Posted: 2022-04-27 Expires: 2022-05-28

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Director, Supply Chain (Pharmaceuticals)

Avadel Management Corporation
Remote, Other

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