Chief Operating Officer — Cell-Therapy Programme

The mandate

A cell-therapy company has entered a co-development agreement that adds two studies, access to a complementary construct and substantial partner funding. The agreement creates strategic reach, but it also doubles the number of active clinical workstreams competing for patient operations, vector, manufacturing slots, quality review and investigator attention. The transaction closed against a high-level capacity case; detailed planning has since revealed overlapping country starts and several dependencies on the same specialist teams.

The organisation is accustomed to rescuing individual programmes. Clinical operations accelerates a site, manufacturing protects a batch, quality resolves an investigation and finance finds contingency. That commitment has delivered important milestones, but it has also normalised conflicting schedules and local escalation. With two companies now relying on common resources, heroic recovery can no longer substitute for an enterprise promise. The partner expects timely visibility, and patient appointments cannot be moved like conventional inventory.

The Chief Operating Officer will own the integrated execution system across clinical operations, patient logistics, technical operations, supply planning, programme management and alliance-delivery interfaces. Quality, medical and safety independence remain intact. The COO’s task is to ensure that commitments are made from a realistic view of patient, site, product and expert capacity, and that risks are resolved at the right level before they become missed procedures or unusable batches.

The perimeter encompasses approximately 900 employees and material partners across the United States and international study locations. The position is on site in Boston and reports to the Chief Executive or designated executive sponsor. It is an urgent replacement and requires visible leadership across clinical sites and manufacturing operations, not remote administration of status reports.

Why this seat is open

The outgoing COO has stepped down for personal reasons after an intensive period of company growth and will support a short, confidential handover. The departure is not connected to misconduct or a specific quality event. The board has broadened the successor remit because the co-development agreement exposes the limitations of separate programme and functional planning.

What you will own

• Build the single operating plan for all active studies, connecting patient forecasts, site readiness, collection appointments, vector, processing slots, release testing, shipment and follow-up.
• Lead an operating perimeter of approximately 900 employees and material partners, with clear authority across clinical operations, technical operations, planning, programme and alliance delivery.
• Translate co-development obligations into executable work, resolving priorities, cost shares, information exchange and escalation with the partner before functional teams receive conflicting requests.
• Establish capacity allocation principles that protect patient commitments and critical evidence milestones rather than rewarding the programme that escalates most forcefully.
• Govern chain of identity and custody across site, logistics and manufacturing interfaces, ensuring schedule recovery never bypasses independent quality controls.
• Control a multi-year operating and external-spend envelope above USD 500 million, including manufacturing reservations, clinical vendors and specialist capacity.
• Create an integrated control room for material risks while retiring recurring meetings that repeat status without decision authority.
• Build successors in clinical operations, supply, programme leadership and alliance delivery and reduce dependency on a small group of crisis-solving executives.

The first 12 months

• Days 1–90: Reconcile every patient and batch commitment, identify double-booked capacity and agree priority principles with the executive team and partner. Stabilise imminent collection and dosing windows, put one owner on each cross-functional risk and reset milestones that cannot be met responsibly. Confirm interim leadership and retention in critical operating roles.
• Months 4–9: Implement integrated planning at patient and resource level, align partner governance to the same evidence and renegotiate external capacity where the portfolio has changed. Establish release and logistics service levels, reduce avoidable schedule changes and close structural causes behind the largest recurring deviations and site delays.
• Months 10–12: Deliver the priority studies within the rebaselined patient and supply windows, demonstrate capacity decisions without executive firefighting and complete the following year’s operating plan with funded contingencies. Move the control room into normal governance and show that leaders below the COO can resolve routine portfolio conflicts.

What the board will measure

• Patient collections, manufacturing starts, releases and doses completed within agreed windows, with reasons for changes visible before patients are affected.
• Capacity allocation consistent with approved portfolio and alliance priorities, and no hidden overbooking of vector, suites, testing or specialist teams.
• Reduction in preventable schedule changes, repeat deviations and emergency freight or overtime attributable to planning failure.
• Partner commitments met or re-agreed through timely evidence, with fewer executive escalations and no competing internal versions of the operating plan.
• Operating and external spend inside the approved USD 500 million-plus perimeter, including explicit cost and service consequences of recovery choices.
• Succession coverage and sustainable workload in critical teams, accompanied by lower reliance on named individual rescuers.

The person

You are a Chief Operating Officer, EVP of operations, global programme leader or integrated development-and-supply executive with at least 28 years in cell and gene therapy, biologics or another patient-specific modality. You have coordinated multiple active studies through constrained manufacturing and site networks. You have controlled at least USD 400 million of annual or programme operating spend and led at least 600 employees and partners.

You understand the physical and human choreography of autologous or similarly complex therapy: patient eligibility, collection, chain of identity, slot reservation, manufacturing, testing, shipment, administration and follow-up. You have made allocation decisions when programmes could not all receive the capacity requested and can explain the principles, evidence and patient consequences used.

Direct alliance experience is essential. You have converted a co-development agreement into operating governance, resolved a priority or cost-share dispute and maintained enough transparency for two organisations to plan against the same facts. You respect independent quality and medical authority and do not use an urgent milestone as permission to blur decision rights.

This is an on-site Boston appointment with regular travel to study and manufacturing locations. The board will consider international candidates with current US experience and a credible relocation plan. The right leader builds disciplined flow without losing empathy for patients or treating development uncertainty as factory variance.

Compensation and terms

The cash base for this appointment is expected to be USD 500,000–750,000; annual performance incentive and long-term participation sit above it. Measures will reflect patient-window reliability, integrated capacity, alliance delivery, quality outcomes, capital control and leadership sustainability. This is a permanent replacement appointment. The company will consider relocation and verified forfeited awards while balancing the urgent transition need.

Confidentiality

The client, co-development partner, studies and operating network remain confidential. Identifying material will be shared through the authorised process after fit and confidentiality protections are complete. Candidates must not contact clinical sites, manufacturers or likely partners to infer the organisation.

Each response must contain no more than 49 words.