Thorben Witte

Director-level operational leader overseeing complex global late-phase clinical development programs in vaccines and respiratory indications. Led programs across up to 32 countries, 550+ sites and ~30,000 patients, valued at >$500M. Matrix leadership of 600+ contributors across 20+ functions. Provide portfolio governance, execution, risk and financial oversight, senior sponsor engagement, proposal and bid defense support, inspection readiness, regulatory strategy, operational excellence and innovation.

Senior leader on accelerated global vaccine & infectious disease programs. Led two COVID vaccine trials valued at $350M+, spanning 6,300+ patients, 120+ sites and 5 countries. Matrix leadership of up to 360 cross‑functional contributors. Ensured delivery on the path to FDA Emergency Use Authorization under extreme timelines, executed 14 interim and final database locks, reduced revenue forecast variance to <4%, stabilized high‑risk programs, and delivered real‑time operational, data and executive reporting.

Senior operational and line leader driving global Clinical Trial Management delivery and transformation post‑restructuring. Line management of 19 CTMs across Europe, Africa and Eastern Europe. Standardized a global CTM operating model enabling cross‑country resourcing. Senior escalation and portfolio oversight for late‑phase respiratory trials. Led COVID‑19 continuity with decentralized delivery; optimized governance, metrics, feasibility, recruitment, and proposal support.

Hired to oversee clinical operations across German sites, line management for a team of local clinical trial managers, and support organizational transition to a global operating model. Promoted within <2 months. - Oversaw operational readiness and study execution, ensuring compliance with ICH-GCP, protocol requirements, and sponsor expectations - Supported implementation of global Clinical Trial Management structure and SOPs - Collaborated with cross-functional teams to support clinical trial delivery

Senior clinical program leader providing line management and operational oversight across Phase I–II clinical trials and strategic sponsor partnerships. Line management and mentoring of Project Managers and cross‑functional teams. Oversaw multiple trials across 4 global units from feasibility through close‑out, ensuring delivery to quality, timeline and budget. Supported executive sponsor engagement, feasibility, proposals, bid defenses, process improvement, SOP development, and operational standardization.

Operational lead supporting global strategic partnerships and portfolio delivery across 4 early‑phase clinical pharmacology units. Provided portfolio oversight for Phase I–II studies, ensuring alignment with sponsor timelines, financial targets and KPIs. Developed performance tracking tools and portfolio dashboards to support governance and executive decisions. Supported feasibility, study placement, proposals and bid defenses, and acted as escalation point for operational risks across global teams.

Global clinical project manager responsible for operational delivery of Phase I–IIa clinical trials for international biotech and pharmaceutical sponsors. Led cross‑functional teams from feasibility through close‑out, managing timelines, budgets, regulatory compliance and sponsor communication across US, EU and APAC programs. Supported business development through feasibility, proposals and bid defense participation; recognized internally for delivery excellence and operational leadership.

Clinical project manager responsible for planning and execution of Phase I clinical trials. Coordinated cross‑functional teams across clinical operations, data management, regulatory and clinical pharmacology. Managed study timelines, budgets, vendors and sponsor communication, ensuring compliance with ICH‑GCP, regulatory requirements and internal quality standards.

Provided operational and administrative support to clinical project management teams. - Supported preparation of regulatory and ethics submission packages - Assisted with project documentation, meeting coordination, and trial master file management - Contributed to operational readiness and clinical trial startup activities

Supported global clinical project management activities during internship assignment in Baltimore, USA. - Assisted in cross-functional study coordination, project tracking, and sponsor reporting - Participated in project meetings and operational planning activities - Gained early exposure to global clinical trial delivery within CRO environment

https://www.goethe-business-school.de/en/master-programs/pharma-mba/start

Student representative, 03/11 - 01/13 -- The Bachelor of Science in Clinical Research is a practice related, internationally-oriented degree course. The internationally recognized degree is validated by the University of Wales. More information available via: http://www.parexel-akademie.de/english/

Activities and Societies: Head of school's ambulance, training and coordination -- Specialized courses: Biology and Chemistry