Jobs at Orca Biotech

Leads the pharmacovigilance function, including safety data review, risk management, regulatory documentation, inspection readiness, signal detection, labeling, and safety governance. Provides cross-functional product safety leadership, oversees regulatory filings and compliance with US and EU requirements, manages resources and budgets, and mentors the pharmacovigilance team in a small biotechnology environment.

Manage cross-functional life sciences projects from initiation through implementation, focusing on CMC, technical operations, manufacturing, quality, supply chain, and clinical initiatives. Own project plans, schedules, risks, dependencies, deliverables, meetings, dashboards, RAID logs, and executive communications. Coordinate regulated implementation activities involving GMP, validation, change controls, and operational readiness while supporting PMO governance and portfolio management.

Support the CEO and President by coordinating executive priorities, preparing board and executive materials, driving cross-functional strategic initiatives, improving operating rhythms, and tracking progress on company priorities. Act as a central coordinator for communication, decision-support, and follow-through across leadership teams to scale organizational effectiveness during the companys transition to commercial-stage.

Own gross-to-net accruals, revenue forecasting, and commercial operating expense planning for a newly commercialized pharmaceutical product. Build accrual methodologies, forecasting models, reserve reconciliations, government pricing calculations, variance analyses, and audit-ready documentation. Partner with Accounting, Market Access, Commercial, auditors, and executive leadership while supporting revenue close, ASC 606 compliance, planning-system implementation, and process automation.

Lead Orca Bios strategic partnership and licensing efforts: source, evaluate, negotiate, execute, and manage collaborations with academia, biotech, and pharma to expand the cell therapy pipeline. Provide scientific and commercial due diligence, build deal structures, advise the C-suite, and align partnerships with regulatory, manufacturing, and commercial strategies to drive value creation.

Orca Bio invites passionate candidates to join their talent community, focusing on transformative next-generation cell therapies and innovative contributions.

Coordinates commercial marketing operations and Medical, Legal, and Regulatory review processes for biotech promotional materials. Manages conferences, campaigns, agencies, vendors, marketing assets, project timelines, and budgets. Facilitates PRC/MRC meetings, administers Veeva PromoMats workflows, performs submission quality checks, tracks material approvals and expirations, and supports FDA Form 2253 submissions while ensuring compliance with applicable regulations.

Monitor clinical studies at investigative sites or remotely, ensuring protocol, ICH-GCP, SOP, and regulatory compliance. Responsibilities include site monitoring visits, source data verification, medical record and adverse event review, site staff support, monitoring report authoring, trial material development, SOP contributions, and eTMF documentation. The role requires CRA experience, preferably in oncology, hematology, or cell and gene therapy, plus proficiency with clinical trial systems and regulatory requirements.