CONTRACTOR- Supply Manager, Expanded Access Program (6 month duration)

Savara Inc.; United States; Remote; USD 100,000 - 130,000; Full time

Job summary

Savara Inc. is seeking a CONTRACTOR Supply Manager for their Expanded Access Program. This role involves managing supply operations, including procurement and distribution of investigational therapies. Ideal candidates will have extensive experience in drug development and strong project management skills, working remotely with occasional travel.

Qualifications

• 5+ years of experience in late-stage global drug development.
• Understanding of clinical trial and EAP protocols.
• Familiarity with GxP compliance and regulatory requirements.

Responsibilities

• Support day-to-day supply operations of Savara EAP.
• Manage labeling/packaging and distribution of investigational supplies.
• Coordinate with key stakeholders for regulatory and distribution requirements.

Skills

Leadership

Project Management

Communication

Attention to Detail

Interpersonal Skills

Education

Advanced health degree

Job description

CONTRACTOR- Supply Manager, Expanded Access Program (6 month duration)

Join to apply for the CONTRACTOR- Supply Manager, Expanded Access Program (6 month duration) role at Savara Inc.

CONTRACTOR- Supply Manager, Expanded Access Program (6 month duration)

Join to apply for the CONTRACTOR- Supply Manager, Expanded Access Program (6 month duration) role at Savara Inc.

This is a 1099 Contractor role with an expected duration of 6 months at 30-40 hours per week. The Contractor will work remotely and should be available to attend meetings during Eastern US business hours. Some travel to Savara HQ outside of Philadephia and other partner or vendor sites may be occassionally required.

The Supply Manager, Expanded Access Programs (EAP) will support the day-to-day supply operations of Savara EAP, including post-trial access, compassionate use, and named patient programs, to provide eligible patients with access to investigational therapy.

Core Responsibilities:

• Supply Planning and Forecasting of IMP and Medical Devices
• Procure ancillary items
• Manage labeling/packaging and distribution of investigational supplies, including medical devices and ancillaries
• Monitor patient activity and inventory levels at clinical sites and depots proactively to mitigate the risk of supply disruption
• Coordinate with key stakeholders for regulatory requirements as well as distribution requirements
• Process and manage shipments requests and inventory at external vendors
• Ensure that Subject Matter Experts (SMEs) are incorporated into decision-making, as appropriate, and that relevant leadership team members are informed and endorse EAP supply strategies

Experience/Skills:

• 5+ years of experience in late-stage global drug development with demonstrated experience with expanded access programs or experience working at a specialty EAP vendor. Similiar experience in Ph 2-3 clinical trials a plus. Advanced health degree or experience within Clinical Operations or Advocacy Relations is a plus
• Understanding of clinical trial and EAP protocols
• Established business operations or project management experience
• Strong cross-functional facilitation and leadership skills
• Knowledge of regulatory and pharmaceutical industry requirements
• Outstanding interpersonal, communication, and relationship-building skills across teams
• Proven oral and written communication skills, including experience developing and delivering presentations to executive management
• Exceptional attention to detail and ability to thrive in a fast-paced, dynamic environment
• Positive, driven, and energetic, with the willingness able to roll up their sleeves to get the job done
• Familiarity with GxP compliance and regulatory requirements
• Experience working in global supply chain environments
• Previous consulting experience is a plus

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Management and Manufacturing

• Industries

  Pharmaceutical Manufacturing

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