Role Overview

Reporting to the Head of Global Advocacy Relations & Patient Engagement, the Sr. Manager, Early Access Programs / Advocacy Relations will support the day-to-day operations of the Savara Early Access Program (EAP), including post-trial access, compassionate use, and named patient programs, to provide eligible patients with access to investigational therapy. Additionally, this role would support educational campaigns, manage the review of grants/partnerships, and contribute to advocacy relations efforts. This person will work cross-functionally and with external EAP and Advocacy vendors.

Core Responsibilities

Early Access Program

• Support the day-to-day operations of the EAP, including post-trial access, named patient, and compassionate use.
• Ensure that Subject Matter Experts (SMEs) are incorporated into decision-making, as appropriate, and that relevant leadership team members are informed/endorse EAP strategies.
• Develop EAP reporting dashboards and metrics to support transparency and decision-making.
• Support Savara’s strong oversight of external EAP vendor partners and operations to manage timelines and ensure excellent service and experience for healthcare providers (HCPs) and patients who participate in the EAP.
• Help guide EAP strategy, operations, and risk management across the organization with key functions including Program Management, Supply Chain/Global Technical Operations, Regulatory Affairs, Quality Assurance, Clinical Development, Clinical Operations, and Finance.
• Coordinate with Clinical Operations and Program Management to streamline post-trial access for eligible patients.
• Collaborate with Program Management, Global Technical Operations, and Regulatory Affairs to fulfill site- or HCP-level regional and local filing and labeling requirements to ensure smooth transition and initiation of eligible patients.
• Coordinate responses to site- or HCP-level inquiries from participating or inquiring HCPs about the EAP including how to apply, register, and order investigational product for eligible patients.
• Facilitate site review, e.g., Institutional Review Board (IRB) review where required, budgeting, and site agreement discussions and negotiations between EAP vendors, sites, HCPs, and internal decision-makers.

Patient Advocacy

• Support the execution of Savara’s global patient advocacy/engagement relations efforts.
• Oversee internal review process to ensure efficient and compliant patient advocacy collateral/activities (manage and document the review of all advocacy-related materials/programming).
• Provide operational support for Savara’s key patient advocacy activities.
• Coordinate with Corporate Affairs on internal/external communications to create awareness for advocacy-related programming.
• Work closely with Head of Advocacy Relations & Patient Engagement on budget management.

Required Experience/Skills

• Bachelor’s or equivalent 4-year university degree required, other advanced health degree or experience within Clinical Operations or Advocacy Relations is a plus.
• 5+ years of experience in late-stage global drug development (broad experience in global early access programs or experience working at a specialty EAP vendor 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, able to roll-up their sleeves to get the job done.

Work Schedule and Location

This role will be remote within the United States. Occasional travel to the corporate office outside of Philadelphia, PA or partner locations will be required. The employee must be able to work a US eastern time schedule.

Savara provides Comprehensive Benefits including

• Highly competitive medical, dental, and vision coverage.
• Flexible Spending Accounts for health care and dependent care expenses.
• Paid time off and paid holidays, including Dec 24-Jan 1.
• Paid parental leave.
• 401k with highly competitive match.
• Life, AD&D, STD and LTD insurance coverage.

Savara’s compensation can include

The base salary for this role is $120,000 to $150,000.

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.