Full-Time

Cell Therapy Case Management Lead

Posted on 10/31/2025

Orca Bio

Orca Bio

201-500 employees

Develops and commercializes safer cell therapies

No salary listed

California, USA

Hybrid

Category
Biology & Biotech (2)
,
Requirements
  • 5–8+ years of experience in patient case management, order coordination, transplant operations, or healthcare call center leadership, preferably in cell or gene therapy, oncology, or complex therapeutics
  • At least 2 years in a team lead or supervisory capacity, with responsibility for scheduling, coaching, mentoring, and daily operations
  • Player-coach mentality
  • Strong understanding of treatment center workflows, transplant coordination, apheresis, and chain-of-identity logistics
  • Excellent interpersonal skills with a service-first mindset and calm, solution-oriented approach to escalation management
  • Strong organizational and problem-solving skills with the ability to work under pressure in a launch-phase environment
  • Experience with call center structure, shift design, or customer service models is a plus
Responsibilities
  • Oversee the daily operations of the case management team, including case assignment, workflow monitoring, coverage, and adherence to service level expectations
  • Create and manage the staffing and scheduling model for the order management/case management function, ensuring optimal patient throughput and site experience
  • Monitor case activity, respond to escalations, and provide real-time support to case managers and treatment centers
  • Lead daily huddles, ensure timely internal communication, and reinforce best practices and SOP compliance
  • Foster a high-performance, best-in-class, service-oriented, and a supportive, cohesive culture within the team
  • Collaborate with Commercial and Technical Operations leadership to define the Orca-T customer service model, including workflows, team structure, escalation protocols, and cross-functional handoffs
  • Define, draft and continuously refine case management SOPs, work instructions, and training materials
  • Contribute to the design and implementation of Orca Bio’s commercial ordering platform
  • After launch, track and report on key performance indicators, identifying trends and opportunities for team optimization
  • Partner with cross-functional stakeholders to resolve operational gaps and improve case handling efficiency

Orca Bio develops and commercializes cell therapies to improve outcomes for patients. It works by researching, developing, and producing therapies that use the body’s own cells to treat diseases, with products sold to healthcare providers who administer them to patients. The company aims to enhance the safety and effectiveness of cell therapies, making treatments more reliable for conditions that lack good options. Orca Bio differentiates itself through its focus on delivering safer, more effective therapies and by fostering a strong team culture with active stakeholder communication, including a regularly updated newsroom. Overall, its goal is to expand access to improved cell therapies and become a leading player in the cell therapy market.

Company Size

201-500

Company Stage

Debt Financing

Total Funding

$542M

Headquarters

Menlo Park, California

Founded

2016

Simplify Jobs

Simplify's Take

What believers are saying

  • FDA extended Orca-T BLA review timeline April 2, 2026, allowing additional data submission strengthening approval case.
  • Steve Gavel joined as Chief Commercial Officer from Legend Biotech, bringing established cell therapy commercialization expertise.
  • $250M Series F funding plus $100M SVB credit facility enables East Coast manufacturing expansion and nationwide distribution.

What critics are saying

  • FDA rejection of Orca-T BLA halts commercialization and destroys $250M investor confidence within 1-3 months.
  • Legend Biotech's established CAR-T infrastructure captures market share, outcompeting Orca-T's unproven allogeneic approach.
  • Cash burn exhausts $250M runway by mid-2027 without approval, forcing pipeline cuts or company shutdown.

What makes Orca Bio unique

  • Orca-T uses purified donor regulatory T cells, reducing immunosuppression versus standard tacrolimus-methotrexate treatment.
  • Single-cell precision manufacturing platform creates consistent, off-the-shelf allogeneic cell therapies across multiple indications.
  • Phase 3 data showed 77% relapse-free survival in older patients with reduced intensity conditioning regimen.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Unlimited Paid Time Off

401(k) Retirement Plan

Parental Leave

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

-1%

2 year growth

-1%
The Pharma Letter
Apr 2nd, 2026
FDA review not plain sailing for Orca.

FDA review not plain sailing for Orca. 2 April 2026 Privately-held US cell therapy company Orca Bio announced that the US Food and Drug Administration (FDA) has extended the review timeline of its Biologics License Application (BLA) for Orca-T for the treatment of patients with hematologic malignancies. This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here. Try before you buy Free. 7 day trial access * All the news that moves the needle in pharma and biotech * Exclusive features, podcasts, interviews, data analyses and commentary from its global network of life sciences reporters. * Receive The Pharma Letter daily news bulletin, free forever. Become a subscriber £820. Or £77 per month * Unfettered access to industry-leading news, commentary and analysis in pharma and biotech. * Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results. * Daily roundup of key events in pharma and biotech. * Monthly in-depth briefings on Boardroom appointments and M&A news. * Choose from a cost-effective annual package or a flexible monthly subscription The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It's part of the key information for keeping me informed Chairman, Sanofi Aventis UK More on this story... 23 March 2026 25 March 2026 1 April 2026 Companies featured in this story. Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news Today's issue. 2 April 2026 Company spotlight. A clinical-stage biotechnology company developing atacicept and other targeted therapies for serious immunological and kidney diseases with high unmet medical need. More features in biotechnology. 2 April 2026

Business Wire
Jan 12th, 2026
Orca Bio Announces $250M in Aggregate Financing in Preparation for Potential Commercialization

Orca Bio announces $250M in aggregate financing to support launch readiness leading up to the Orca-T® PDUFA date of April 6, 2026.

Silicon Valley Daily
Jan 10th, 2026
Orca Bio Secures $250 Million in Financing

Orca Bio secures $250 million in financing. MENLO PARK - Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, has completed a Series F financing round led by Lightspeed Venture Partners. With $250 million in new equity capital from its two most recent financing rounds, along with a 2025 amendment to its Silicon Valley Bank credit facility providing up to $100 million in additional liquidity, Orca Bio possesses the financial strength to scale its commercial operations and advance its clinical pipeline. The proceeds will be used to ensure commercial readiness as the company approaches the April 6, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Orca-T, Orca Bio's lead investigational allogeneic T-cell immunotherapy. The funding will help strengthen the company's infrastructure to support future commercial scale, including the addition of East Coast manufacturing capacity to complement its Sacramento, CA operations. The capital will also support the accelerated advancement of Orca Bio's pipeline across multiple clinical programs designed to expand treatment to more patients in need.

FiercePharma
Jan 9th, 2026
Orca Bio secures $250M to prepare blood cancer cell therapy for commercial launch

Orca Bio has raised $250 million across two funding rounds to prepare for the commercialisation of its blood cancer cell therapy Orca-T. The California-based biotech also secured up to $100 million in credit from Silicon Valley Bank. Orca filed for FDA approval of Orca-T last year, with a decision expected by 6 April. The allogeneic T-cell immunotherapy uses purified donor regulatory T cells to prevent graft-versus-host disease with less immunosuppression than conventional transplantation methods. A phase 3 trial showed significantly better survival outcomes compared to standard tacrolimus and methotrexate treatment. The funding will support manufacturing expansion, including new East Coast capacity. Mike Hirschmann, formerly of Legend Biotech, now leads commercial operations following leadership changes last year.

Orca Bio
Jan 9th, 2026
Orca Bio Announces $250M in Aggregate Financing in Preparation for Potential Commercialization - Orca Bio

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