Patrick Ezeh

About Patrick Ezeh

Clinical Operations and Clinical Development Professional with over 20 years of Clinical Operations, Technical and Leadership experience in Big as well as Mid/Small size Pharmaceutical Organizations and Global CRO. Extensive experience in clinical operations and clinical development. Excellent and broad understanding of Research and Development as well as the entire drug development value chain. Expertise in all aspects of clinical Operations in different therapeutic areas including but not limited to Oncology, Neuroscience (CNS), Infectious Diseases, Rare Diseases, Inflammation among others and extensive experience managing multiple assets at the same time. Global Clinical Operations and Development Leader in different Phases of Drug Development. Overall responsibility for clinical operations strategy, proactive planning, risk management and clinical program/study execution. Strong program and project management skills responsible for cross-functional development of company’s product pipeline. Works collaboratively with program teams to manage and integrate the diverse R&D and commercial activities of drug development through interactions with different functional lines and external parties for outsourced activities. Technical and leadership experience in large, midsize global pharmaceutical companies as well as Contract Research Organization spanning exploratory development and all other phases of drug development. Other areas of expertise include: Clinical Development, Clinical Operations, Drug development, cross-functional team leadership, vendor oversight/management, risk management.

Experience

1. Director, Clinical Program Leadership

   Biogen

   Apr 2019 — Present · Cambridge, MA, US

   As a senior member of the CPL and GCO organization, I am responsible for a portfolio of clinical programs within and across therapeutic area(s). In this capacity I oversee and provide key strategic and operational guidance in the planning and delivery of assigned programs and of the operational innovation that is necessary to optimally execute programs in the assigned therapeutic area(s).Provides guidance and oversight to individuals in the CPL organization on CDP strategy and operational execution. Actively maintains relationships with appropriate key internal senior stakeholders (eg therapeutic or program level clinical leadership in Late Stage Development, Early Stage Development). Facilitates the flow of critical information to these individuals on behalf of GCO.Evaluates ongoing operational, strategic and resource needs of programs in assigned therapeutic area(s), providing input both internal and external to GCO. Reviews and provides management input into key deliverables from the CPL organization (eg, materials and documents for key governance forums).Point of escalation from the clinical program level within GCO and for external stakeholders (key vendors, management in other parts of the Biogen organization)May provide strategic input in the evaluation and planning for external business opportunities (eg diligence reviews)Provides people leadership and mentorship to individuals in the CPL organization.Provides GCO Leadership with insight into CDP issues, risks and mitigations in assigned therapeutic area(s). As a leader in GCO and CPL actively contributes to creating and embedding a culture of excellence. Actively contributes to the development of the necessary process, tools and standards necessary establish world class CPL and GCO organization.Represents the GCO organization as needed in important organizational initiative and projects. May lead critical initiatives or projects.

Education

• Auburn University

  Ph.D., Neuroscience

• University of Nigeria, Nsukka

  D.V.M.

• Tuskegee University

  M.S., Pharmacology

Skills

• Clinical Research
• Regulatory Requirements
• Pharmacokinetics
• Drug Development
• Good Clinical Practice (Gcp)
• Gcp
• Biopharmaceuticals
• Pharmacovigilance
• Gmp
• Medical Writing
• Biotechnology
• Cross-Functional Team Leadership
• Infectious Diseases
• Clinical Development
• 21 Cfr Part 11
• Biosimilars
• Glp
• U.s. Title 21 Cfr Part 11 Regulation
• Pharmaceutics
• Drug Discovery
• Validation
• Oncology
• CRO
• CRO Management
• Life Sciences
• Vaccines
• Clinical Trials
• Technology Transfer
• Biomarkers
• Therapeutic Areas
• Pharmacology
• Ctms
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Submissions
• Regulatory Affairs
• Lifesciences