Christian Hucke

Project Management in Clinical Development / Operations

• Leading or supporting cross-functional program teams
• Serving as Clinical Project Lead / Clinical Study Manager
• From pre-clinical stage to Phase III

Interim Management

• Serving as acting lead role (e.g., Head of Clinical Operations, VP Operations, COO)
• Building and shaping new structures or functions (e.g., establishment of structures and processes for running clinical trials under EU CTR 536/2014)

Project Management in non-clinical projects

• Leading task forces
• Management of projects from areas other than clinical development (e.g., Medical Affairs)

Quality Risk Management

• Process gap analysis, process improvement and SOP writing
• Establishment of Quality Risk Management processes and oversight concepts for clinical studies and programs

Dr. Christian Hucke is a pro-active and hands-on senior manager with 20 years of experience in global Clinical Development and Operations. He founded Christian Hucke Pharma Consulting and Services in 2016. Prior to becoming a consultant he held project management and line management positions in CROs, Pharma and Biotech companies.

As a project manager Dr. Christian Hucke has led multi-disciplinary matrix teams with responsibility for activities in the EU, USA, CEE, LATAM and APAC. As a line manager he served as Head of Clinical Operations in a Biotech company and as Chief Operating Officer in a CRO.

Dr. Christian Hucke has managed projects and clinical studies from R2D transition to phase III in various indications, among them oncology and hematology (CRC, HL, NHL), CNS (ischemic stroke, pain, psycological disorders), ophtalmology (uveitis) and infections (SARS-CoV-2). Projects included personalized medicine approaches, technology platforms ranged from small molecules to antibodies, peptides, and mRNA.

The track record of Dr. Christian Hucke further includes the participation in authority meetings and inspections (e.g., FDA, PEI, MHRA, ANSM; German local authorities), leading task forces, Quality Management in GCP/GCLP, establishment and execution of Risk Management and oversight concepts, and corporate development projects.

Education: Biologist, PhD

Areas of Expertise: Interim Management, Project Management, Clinical Operations, Quality Risk Management

Selection of current and past services:

• Interim Head of Clinical Operations (Biotech)
• Task Force Lead for selection of a new bioanalytic lab and management of the technology transfer process (Biotech)
• Technical Project Management: pre-clinical development of a sustained release formulation for a biologic (Biotech)
• Program Team Lead and representation of Clinical Development/Operations for development of an antidepressant (Biotech)
• Establishment of overarching Project Management standard processes (Biotech)
• Acting Clinical Operations Program Manager (Biotech)
• Clinical Study Manager for phases I, II and observational studies, various indications (Biotech)
• Project Manager for the development and rollout of a Global Medical Affairs guideline (Big Pharma)
• QRM, audits and process gap analysis for inspection readiness; consulting for conduct of a pivotal phase III study (Pharma)