• Provide surge execution support for launches, major tool/process releases, and high-impact organizational changes, ensuring clear sequencing, ownership, and follow-through. • Translate launch/change plans into practical field actions (readiness tasks, cutover steps, stabilization activities), ensuring clarity on who does what by when. • Identify cross-team dependencies and readiness risks early (training gaps, workflow breaks, operational constraints) and drive mitigation actions with owners. • Support cutover planning and go-live readiness, including readiness checklists, field-facing timing clarity, and escalation pathways for high-severity issues. • Coordinate hypercare mechanics during launch/change windows to ensure rapid triage, clear ownership, and timely resolution of field-impacting issues. • Drive rapid stabilization by tracking issues through to closure and ensuring recurring problems are addressed with root-cause fixes, not repeated workarounds. • Partner across teams to align execution details (timelines, readiness expectations, support model) and reduce last-minute churn during launch windows. • Maintain an integrated view of launch/change readiness signals and surface actionable watch-outs to execution leadership. • Capture lessons learned and convert them into improved readiness playbooks, templates, and standard operating patterns.

• Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery system development programs • Support the drug-led CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activities • Lead technical content writing and review in autoinjector (other device)/integral combination product documentation including IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations and responses to health authority questions per established business processes and systems • Identify, communicate, and escalate potential issues to Regulatory CMC Product Lead and Device Quality & Regulatory Affairs Leadership • Apply an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our human medicinal products worldwide

• Responsible for the financial and operations oversight of clinical delivery across a portfolio of studies. • Partner with Regional Heads within the Clinical Network to ensure appropriate resourcing and productivity levels within the portfolio of studies. • Ensures that assigned clinical staff understand and perform consistently according to defined operational, financial, and quality performance and process standards. • Maximize contribution margin across clinical delivery through strong financial stewardship and accountability across the portfolio of studies. • Uses established operational, financial and quality metrics and reporting dashboards to assess overall portfolio health and take action where necessary. • Participates in risk management activities across the assigned portfolio of studies. • Drives and supports and facilitates a learning organization. • Engages with leadership to help drive and implement initiatives which aim to improve performance of the business. • Helps to define and implement the company and department vision and strategy; translates this into key initiatives and priorities.

• Own execution planning and alignment for initiatives that span multiple Therapeutic Areas or do not sit within a single TA • Coordinate execution across enterprise and system accounts (e.g., IDNs), ensuring consistent prioritization and engagement approach • Serve as the primary owner for enterprise-level execution challenges and escalations that fall outside TA boundaries • Ensure execution plans are forward-looking, anticipating future needs rather than reacting to current issues • Shape cross-TA initiatives upstream, ensuring sequencing, readiness, and dependencies are clearly defined before execution • Identify emerging system-level risks and misalignments and proactively drive resolution • Align stakeholders across Therapeutic Areas and functions to ensure enterprise-level consistency • Resolve conflicts in priorities, timing, or execution expectations across TA boundaries • Own resolution of complex cross-TA execution issues requiring enterprise-level coordination • Drive structured issue management, ensuring clarity of ownership and follow-through