Orca

Program Manager

• Serve as the primary operational liaison to NMDP and other registry partners across clinical and commercial programs.
• Manage the full domestic and international registry partnership lifecycle: onboarding, alignment, issue escalation, and business reviews.
• Track and monitor registry, donor center, and apheresis center performance against service levels; identify and drive resolution of operational gaps.
• Serve as the single point of contact internally and externally for issue reporting and resolution.
• Design, implement, and continuously improve scalable donor cell acquisition processes supporting the commercial launch of Orca-T and Orca Bio's clinical programs, incorporating transplant center feedback and industry best practices.
• Author SOPs, work instructions, and process maps.
• Inform OrcaLink (clinical and commercial scheduling and coordination system) product requirements for donor request workflows, with emphasis on transplant center experience and legal/regulatory compliance.
• Assess capacity constraints in apheresis and patient operations infrastructure across the transplant center and registry network and proactively engage partners on solutions.

Donor Services Program Manager

Compliance

• Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program that aligns with industry standards and regulatory requirements, including federal, state, and international regulations, as appropriate.
• Develop policies and procedures that provide appropriate guidance and instruction to Company employees.
• Lead the development and delivery of compliance training programs for employees at all levels.
• Conduct regular compliance audits, monitoring and risk assessments to identify potential areas of compliance vulnerability and risk.
• Assist in the completion of activities related to federal and relevant state transparency-driven compliance requirements.
• Manage the Company’s whistleblower hotline.
• Collaborate with legal, regulatory, and operational teams to provide compliance guidance and support for new initiatives and projects.
• Investigate compliance-related issues and coordinate with relevant stakeholders to ensure appropriate corrective actions are taken.
• Stay current with industry trends, regulatory changes, and best practices in compliance.
• Engage in such other activities as directed by the Senior Vice President, Legal.

Senior Manager – Healthcare Compliance

Research Analyst

• Responsible for monitoring the progress of clinical studies, either at investigative sites or remotely
• Ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH-GCP, and all applicable regulatory requirements
• Conduct interim monitoring visits (IMVs) and ISF review
• Review electronic medical records (EMR)/patient data
• Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors and ensuring good documentation practices
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting
• Provide support to site staff including research coordinators and physicians
• Assist in the development of trial materials as needed
• Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates
• Author and submit high-quality monitoring visit reports within required timelines
• Ensure completeness and accuracy of monitoring documentation in the eTMF

Clinical Research Associate

Product Manager

• Partner with the CEO on product strategy — bringing your own point of view, challenging assumptions, and translating shared vision into a clear prioritized roadmap with defined success criteria.
• Own the portfolio of product initiatives: recommend what gets started, advocate for what gets killed, and manage tradeoffs across product initiatives and future bets.
• Lead and develop a team of product managers, designers, and UX researchers — with full accountability for team performance, hiring, and coaching your team to help them grow.
• Set the standard of what good looks like for the product team — from how we run meetings and capture decisions, to how we transfer context across functions — and hold the team to that standard.
• Drive cross-functional execution alongside Engineering, BD, Design, and Marketing. You’ll define and implement product operating standards, and you're not above getting into the details when it matters.
• Define, track, and report on product KPIs that tie directly to business objectives — you believe in and champion a data driven culture where what we ship produces measurable business value.
• Act as the voice of the customer and the market, synthesizing qualitative and quantitative signals into clear product decisions.

Head of Product

Marketing

• Leads the promotional launch of Orca-T, driving robust pre-launch, launch, and post-launch strategies and omnichannel tactics that maximize market penetration and product adoption
• Drives development of unique and effective HCP engagement strategies aligned to Orca-T Brand strategy
• Collaborate with the Market Development team and other Commercial personnel to shape a comprehensive HCP Marketing tactical plan, budget, and performance plan aligned to Brand KPIs to enable a robust promotional launch
• Lead Orca-T message development across HCP and patient audiences, including insights generation and analysis
• Lead the execution of a full HCP-facing tactical suite for personal and non-personal channels, including PRC review and approval, for Day 0, Now Approved, and Campaign assets
• Contribute to omnichannel strategy, deployment, and management
• Manage agency partners effectively to deliver consistent results
• Contribute to advisory board content, execution, and analysis
• KOL Engagement at major congresses, advisory boards, and site visits as necessary to support Commercial onboarding workstreams
• Lead consistent engagement with Sales team to ensure optimization of messaging and assets
• Effectively manage the promotions tactical budget to Launch Readiness and Orca-T launch
• Manage one Product Marketing FTE

Donor Services Program Manager

Senior Manager – Healthcare Compliance

Clinical Research Associate

Head of Product

Director, Marketing – Brand Lead