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Associate Director/Director, Clinical Supply

9709029b-8016-4939-9547-ed17adacef78

PA, US$140,000 - $200,0004 weeks ago
30 views8 saves0 applies

Benefits

Health InsuranceDental & VisionPaid Time OffParental Leave401kRetirement Plan

Job Type

full time

Description

Job Summary

Reporting to the Executive Director, Logistics & Supply Chain, the Associate Director/Director, Clinical Supply will be instrumental in ensuring the availability of supply to patients currently receiving Molgramostim treatment in our clinical trial and expanded access programs. The individual will serve as a key point of contact cross-functionally within the organization.

Core Responsibilities

  • Works with internal stakeholders to translate clinical study forecasts into clinical supply plans. Key functions include planning, procurement, labeling/packaging and distribution of clinical supplies and/or ancillary supplies for all investigational programs.
  • With guidance from the Executive Director, Logistics & Supply Chain, maintains the overall labeling, packaging, and distribution strategy for all investigational programs.
  • Oversees the management of clinical supply activities at clinical packagers and depots to ensure efficient utilization of supply.
  • Manage label lifecycle process to ensure compliance with regulatory requirements.
  • Monitor patient activity and inventory levels at clinical sites and depots proactively to mitigate the risk of a supply disruption.
  • Manage funds and resources efficiently and with an entrepreneurial approach to ensure budgetary compliance.
  • SOP/Work Instruction development and management to support day to day operations.
  • Work with CROs to ensure import/export requirements are evaluated to enable the compliant movement of supply.
  • Other duties and projects as assigned.

Required Qualifications

  • Bachelor’s degree required
  • 5+ years experience in planning, scheduling, and coordination of clinical supply activities globally
  • Strong GXP focus and compliance mindset
  • Demonstrated experience with implementing and managing inventory systems (IRT)
  • Ability to foster teamwork and project management within a cross- functional environment is critical
  • Strong interpersonal and communication skills and the ability to effectively drive performance
  • Excellent written and verbal communication skills in English
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to shifting priorities and deadlines
  • Experience in managing external service providers (e.g., Clinical packagers, CDMOs, consultants, vendors)
  • Proven ability to develop exceptional relationships and have an impact on or appropriately influence others
  • Experience working in a start-up and/or mid-cap sized company highly desired
  • Proficient in the use of Microsoft Applications (Excel, Project, SharePoint, Word)

Work Schedule and Location

  • This role is remote within the US and requires availability to work US Eastern Time Zone.
  • Travel to Savara's HQ outside of Philadelphia will be occassionally required.

Savara provides Comprehensive Benefits including:

  • Medical, dental, and vision coverage
  • Flexible Spending Account for health care and dependent care expenses and Health Savings Account
  • Paid time off and paid holidays, including Dec 24-Jan 1
  • Paid parental leave
  • 401(k) with highly competitive match
  • Life, AD&D, STD and LTD insurance coverage
  • Other supplemental insurance programs

Savara’s compensation for this role will include a base salary, bonus, and equity. This role will be filled at the Associate Director or Director level. The base salary range for this role is $140,000 to $200,000.

About Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.

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Skills

procurementexcelproject management