Savara Inc. · 6 hours ago

Director/Senior Director, Early Access Programs

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$195K/yr - $235K/yr

10+ years exp

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Responsibilities

Lead and be responsible for the day-to-day operations of the Early Access Program (EAP), including post-trial access, named patient, and compassionate use. Drive strategy and core decisions through facilitation with the EAP Executive Committee.

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.

Manage and lead Savara’s strong oversight of external EAP vendor partners and operations to manage timelines and ensure excellent service and experience for HCPs and patients who participate in the EAP.

Provide hands-on execution expertise to 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 regional and local filing and labeling requirements to ensure smooth transition and initiation of eligible patients.

Shepherd the writing, review, approval, and maintenance of all EAP policies, procedures, and related documents (including regional protocols, ICFs, and IFUs that require update as well as Risk Management documentation and related SOPs). Ensure that all EAP activities are managed in accordance with Savara policies and procedures as well as global and local regulatory jurisdictional laws and regulations.

Respond to 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., IRB review where required), budgeting, and site agreement discussions and negotiations between EAP vendors, sites, HCPs, and internal decision-makers.

Partner with Project Management, Commercial, Market Access, and Patient Services to ensure a comprehensive, integrated plan to transition from EAP to Commercial.

Act as central point of contact/knowledge “hub” for all things related to Savara’s EAP.

Qualification

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Global drug developmentEarly Access ProgramsClinical OperationsRegulatory AffairsCross-functional facilitationDynamic environment adaptability