Executive Director Clinical Operations, Program Management; Cell Therapy

Job Title:

Executive Director Clinical Operations, Program Management (Cell Therapy/ Car-T)

Locations:
US based (Gaithersburg, MD, Boston, MA, SSF, CA, Santa Clara, CA)

• Are you ready to lead global cell therapy clinical operations across multiple franchises and turn bold science into real options for patients?
• This role puts you at the helm of program-level delivery for early development in vivo, allogeneic, and autologous cell therapies, spanning therapeutic areas from cancer to autoimmune disease.
• You will translate strategy into execution across a complex, high-stakes portfolio where time, cost, and quality are mission critical.
• Reporting to the Head of Cell Therapy Clinical Operations, you will partner with senior operational and clinical leaders to shape franchise strategies, drive standardization, and ensure inspection-ready excellence.
• How would you set the standard for operational delivery while scaling a 50+ person global team across five countries and aligning shared functions like data, logistics, and manufacturing to a cohesive cell therapy strategy?

Franchise Leadership: Clinical Operations Strategy:
Define and implement short- and long-term clinical operations strategies across franchises, including therapeutic operating models, country footprint and site strategies, and consistent, deliverable operational clinical development plans.

Integrated Portfolio Delivery: Provide direct strategic oversight of global cell therapy clinical studies to deliver to agreed time and cost, meeting quality and regulatory standards across the portfolio.

Governance and Decision Quality
:
Serve as a core member of enterprise governance for cell therapy, including Protocol Review Committee sign-off for clinical operations and robust operational review ahead of key decision bodies (DRC and ESPC/LSPC).

Prioritization and Forecasting: Establish and communicate delivery strategies, portfolio priorities, and key metrics to leadership; partner with planning leaders to drive slot forecasting and prioritization decisions.

Regulatory and Inspection Readiness: Ensure franchise-wide preparation for regulatory submissions and sustained inspection readiness. Functional Leadership: High-Performing Teams:
Build and inspire a strong, capable global team across program leadership roles, setting vision and strategy, elevating performance, and developing capabilities at scale.

Operational Excellence
:
Lead functional delivery including financial cycle planning (MTP, LTP, phased budget), training and onboarding strategies, and functional budget management.

Cross-Functional Integration: Build deep partnerships with shared functions (Data Management, Vendor Management, Lab Management groups, Logistics, Manufacturing) to co-create and execute fit-for-purpose cell therapy strategies.

External Engagement and Innovation: Engage with industry leaders to bring innovation into clinical operations practice; lead large transformational work streams within and beyond the function.

Leadership Team Contribution: Serve as a key member of the leadership team, shaping the forward plan and ensuring standardization and consistency of delivery across programs.

• Bachelor’s degree or equivalent
• 12+ years of proven Drug Development experience, with direct experience in clinical drug development setting, including direct clinical operations experience
• Line management expertise; experience of performance management of Snr Director level Staff in a large pharmaceutical or biotech setting of teams of 20+.
• Demonstrated development of others, identifying and providing opportunities to improve the capabilities of other people
• Functional Experience in contributing meaningfully to Clinical Operations functional improvement initiatives that cross clinical programs management experience, managing resourcing, budget planning and functional level activities
• Professional excellence:
  Background of high professional achievement and willingness to encourage this in others
  - Leads change with a positive approach; sees change as an opportunity to improve performance and add value to the business
• Influencing and stakeholder management
• Supplier/Partnership Management
• Excellent communication skills
  - Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment
• Creative and Innovative:
  Seeks to improve continuously where it counts, based on good awareness of external competitive…