Own relationships and operational readiness across Authorized Treatment Centers, coordinating cross-functional support, educating site teams, and improving appropriate use of approved cell therapies.
Orcabiosystems jobs
Orca Bio focuses on cell therapy.
15 open roles at Orcabiosystems
Leads end-to-end onboarding for commercial treatment sites, coordinating internal teams and clients, assessing quality and compliance, and improving processes to support successful implementation and ongoing operations.
Leads and develops the national Medical Science Liaison organization, translating medical strategy into field initiatives, guiding scientific engagement and clinical-trial support, and ensuring compliant, high-quality execution.
Coordinates commercial marketing projects, medical conference logistics, vendor workflows, and promotional material management while supporting compliant Medical/Legal/Regulatory reviews in Veeva Vault PromoMats.
Medical Science Liaison - Great Lakes (IL, MI, MN, WI, IN, IA, ND, SD)
Build scientific partnerships with transplant and cell therapy experts, guide investigator-sponsored research, communicate clinical insights, and support medical strategy for advanced allogeneic cell therapies.
Secures coverage and reimbursement for cell therapy products by developing payer strategies, managing payer and hospital relationships, and resolving access barriers to support treatment-center onboarding and patient access.
Own the trade, distribution, and patient assistance strategy and operations, overseeing 3PL and specialty pharmacy partners and ensuring reliable, compliant product ordering, delivery, and fulfillment.
Leads U.S. payer account directors and sets market access strategy for TREGZI, advancing payer access, reimbursement, pricing, evidence planning, and commercialization while supporting team and business performance.
Monitor clinical studies at investigative sites or remotely, ensuring trials are conducted, documented, and reported in compliance with protocols, SOPs, ICH-GCP, and applicable regulations.
Leads the pharmacovigilance safety function and team, overseeing product risk management, safety data review, regulatory documentation and inspections, and safety governance across clinical and regulatory activities.
Build scientific partnerships with transplant and cell therapy experts, guide investigator-sponsored research, and translate clinical evidence and stakeholder insights into medical strategy for advanced cellular therapies.
Leads daily operations for a national cell therapy case management team, overseeing patient coordination, escalations, staffing, and service quality while scaling workflows and improving cross-functional delivery.
Reviews and assesses adverse event reports for investigational products, supports regulatory safety reporting, and coordinates case quality, follow-up queries, and safety database operations.
Leads Regulatory Affairs strategy and execution, with an immediate focus on post-approval operations, product lifecycle management, health-authority engagement, and regulatory readiness for future programs and markets.
Provide off-shift Level 1 and 2 IT support for manufacturing systems, troubleshoot production-impacting issues, and maintain electronic batch records and controlled documentation under established protocols.
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