Operational Excellence Lead I (PharmD)

Replimune•Woburn, MA

2d•$170,000 - $218,000•Remote

About The Position

Replimune is seeking a highly motivated and proactive Operational Excellence Lead I (PharmD) to serve as a field-based subject matter expert responsible for supporting the successful integration of RP1 into treatment centers across the United States. Working as a member of the Operational Launch Excellence Team, this individual will work in close collaboration with field sales and other staff to partner with treatment centers to assess operational readiness, facilitate Operational Workflow Meetings, identify implementation barriers, and optimize workflows to ensure successful adoption of RP1. The successful candidate will collaborate closely with multi-disciplinary care teams including but not limited to, medical oncology, pharmacy, nursing, interventional radiology, and practice leadership to help sites across the US operationalize RP1 and deliver positive treatment experiences. This individual will also contribute to the development of best practices, site readiness tools, and operational playbooks that can be scaled across the organization and adapted to future product launches. This is a field-based position that involves a substantial travel commitment.

Requirements

Bachelor's Degree required, advanced PharmD degree or related studies preferred.
5+ years of relevant experience in biotechnology, pharmaceutical, healthcare operations, oncology, specialty therapeutics, or clinical practice.
2+ years of experience in clinical pharmacy in an academic or community setting is strongly preferred.
Experience launching oncology products in a specialty or hospital-based environment is strongly preferred.
Experience in logistics/receipt of cold chain product, including but not limited to, confirmation of temperature monitoring data and correct storage of product in an institutional setting.
Understanding of applicable regulatory guidelines and regulations and knowledge of IRT/IVRS/IXRS functions, or similar inventory management system.
Demonstrated success working with multidisciplinary healthcare teams.
Experience supporting oncology and/or specialty treatment centers.
Strong understanding of healthcare operational workflows.
Advanced facilitation, presentation, and stakeholder engagement skills; in particular, ability to facilitate workstream meetings related to area of professional expertise in an industry setting.
Strong project management and problem-solving capabilities.
Ability to travel extensively (50-75%).

Nice To Haves

Board Certified Oncology Pharmacist (BCOP) certification is a plus

Responsibilities

Conduct site readiness assessments for targeted treatment centers in area of professional expertise.
Support implementation of the RP1 Site Readiness strategy.
Partner with treatment centers to evaluate operational workflows, identify potential gaps, and develop action plans – with a particular emphasis in area of professional expertise.
Ensure sites are prepared to successfully operationalize RP1 prior to first patient treatment.
Assist sites in navigating the unique operational requirements associated with RP1, including product storage, thawing, scheduling, administration logistics, and multidisciplinary care coordination.
Help facilitate Operational Workflow Meetings with Medical Oncologists, Surgical Oncologists, Interventional Radiologists, Oncology Nurses, Advanced Practice Providers, Pharmacists, Practice Administrators and the Scheduling and Operations Personnel.
In particular, take a leading role in preparing and facilitating meetings and/or workstreams in area of professional expertise.
Conduct workflow mapping exercises to identify potential barriers and opportunities for optimization.
Document site decisions, action items, and follow-up requirements.
Provide recommendations based on established best practices and experience across treatment centers.
Execute timely follow-up with sites to ensure implementation plans are progressing as intended.
Develop expertise in operationalizing RP1 as an intratumorally administered oncolytic viral therapy, especially in area of professional expertise.
Become proficient in: RP1 storage and handling requirements, Ultra-cold chain logistics, Product thawing and pharmacy workflows, Injection scheduling considerations, Live-virus biologic handling procedures, Interventional Radiology workflows, Multidisciplinary patient care coordination.
Capture operational learnings and insights from treatment centers.
Identify emerging best practices and opportunities for process improvement.
Contribute to the creation of workflow playbooks, readiness assessments, meeting materials, and implementation tools; take a lead role in area of professional expertise.
Share learnings and best practices internally with Commercial, Medical Affairs, Training, and other functional teams.
Establish credibility and trusted partnerships with treatment center stakeholders, especially in area of professional expertise.
Support treatment centers throughout onboarding and early adoption phases.
Monitor site progress and identify opportunities for workflow optimization.
Promote consistency in implementation approaches across treatment centers with similar characteristics while adapting to site-specific constraints.