Open to opportunities

Niina Hammoud

@niinahammoud

Message

Senior clinical research leader delivering global vaccine and oncology trials on time and on budget.

Finland

Message

What I'm looking for

I seek senior clinical operations roles leading global vaccine, infectious disease or oncology trials where I can drive end-to-end delivery, mentor teams, and improve processes.

I am a senior clinical research leader with over 20 years' experience delivering complex global vaccine, infectious disease and oncology trials from start-up through final clinical study report. I lead cross-functional teams, manage budgets and vendors, and ensure regulatory and inspection readiness across regions.

My work includes end-to-end accountability for trial delivery, oversight of CROs and central labs, budget forecasting, and risk mitigation for Phase 2–3 randomized and multi-center studies. I have led regulatory submissions (EU CTR, RoW), capacity building in research-limited settings, and managed funder relationships (e.g., CEPI).

I bring hands-on clinical operations experience—site selection, training, monitoring, protocol and safety document development—and a track record of improving processes and harmonizing SOPs to drive quality and compliance.

Experience

Work history, roles, and key accomplishments

Current

Associate Director, Clinical Trial Leader

Current

Johnson and Johnson

Jun 2020 - Present (5 years 8 months)

End-to-end accountability for oncology and vaccines clinical trials, owning delivery, budget, timelines and quality for studies (including Ebola) and managing cross-functional teams and vendors to meet milestones and funder requirements.

Clinical Trial Management Budgeting & Forecasting Regulatory Submissions Risk Management Capacity Building Stakeholder Management

Senior Clinical Trial Manager

Johnson and Johnson

Nov 2016 - May 2020 (3 years 6 months)

Managed global/regional vaccine and immunology trials, led study management teams, oversaw country/site selection, vendor management and budget vs. forecast to ensure enrollment and study milestones were met.

Study Start Up Site Selection Management Vendor Management Budget Management Enrollment management CTMS Risk Management

Senior Clinical Trial Leader

GlaxoSmithKline

Apr 2015 - Oct 2016 (1 year 6 months)

Led Phase 2/3 vaccine studies across multiple countries with end-to-end responsibility including protocol and submission packages, systems readiness, inspection readiness and CRO/vendor oversight.

Regulatory Submissions CRO Protocol & IB Contributions Budgeting

Senior Clinical Trial Leader

Novartis Vaccines and Diagnostics

Mar 2013 - Mar 2015 (2 years)

Oversaw multi-country Phase 2/3 vaccine studies from feasibility to CSR, managing cross-functional teams, vendor performance, submissions and process/SOP harmonization.

Clinical Operations Multi Country Trials CTMS Regulatory Submissions Budget Management

International Clinical Study Manager

Astellas Pharma

Aug 2011 - Feb 2013 (1 year 6 months)

Led international randomized safety and efficacy studies from start-up to final CSR including protocol finalization, CRO contracting, IVRS/IRT setup, IRB/RA submissions and site training.

Study Start Up IVR IRB Submission Recruitment Management Risk Management

Clinical Operations Manager

Intercell AG

Jun 2010 - Jul 2011 (1 year 1 month)

Managed Phase 3 vaccine trials end-to-end ensuring ICH-GCP and regulatory compliance, CRO oversight, budget tracking and cross-functional coordination for trial deliverables and quality.

ICH GCP CRO Budgeting Investigator Meetings Vendor Management

Study Coordinator

Allgemeines Krankenhaus

Apr 2008 - Jan 2010 (1 year 9 months)

Coordinated cancer clinical studies including consenting, study visits, CRF completion, sample processing/shipping and audit support to maintain GCP-compliant study conduct.

CRF GCP Audit Support

Research Study Assistant

Memorial Sloan-Kettering Cancer Center

Jan 2006 - Dec 2007 (1 year 11 months)

Supported hepatobiliary surgery research studies by managing recruitment, regulatory submissions, data collection and SAE reporting while ensuring compliance with GCP and institutional requirements.

Patient Recruitment Data Abstraction Regulatory Submissions SAE Reporting GCP

Research Technician

Memorial Sloan-Kettering Cancer Center

Jan 2005 - Dec 2006 (1 year 11 months)

Performed molecular and cell biology experiments including nucleic acid and protein isolation and standard techniques (PCR, blotting) supporting cancer research projects.

PCR Molecular Biology

Scientific Adviser

European Commission Delegation to the United Nations

Jan 2003 - Dec 2004 (1 year 11 months)

Advised on UN agenda items related to environment, biodiversity and sustainable development and represented EU positions at UN General Assembly negotiations.

Negotiation Environmental Policy Research Analysis

Project Manager

Biosolution

Jan 2001 - Dec 2001 (11 months)

Researched bacterial pathogens and analyzed the US vaccine market, supporting industry liaison and event organization for vaccine-related initiatives.

Market Research Vaccine Industry Liaison Project Coordination Technical Writing

Education

Degrees, certifications, and relevant coursework

Vienna School of Clinical Research

Certificate, Clinical Research Project Management

2011 - 2011

Activities and societies: 16 European CME credits (ECMEC)

Project Management in Clinical Research course (16 European CME credits) focusing on clinical research operations and project management.

University of Vienna

Certificate, German Language

2010 - 2010

German language course undertaken at the University of Vienna.

New York University School of Continuing and Professional Studies

Certificate, International Negotiation

2004 - 2004

One-semester program on International Negotiation at NYU School of Continuing and Professional Studies.

Aalto University (Helsinki University of Technology)

Master of Science, Microbiology / Bioprocessing

1994 - 2001

Activities and societies: Extensive laboratory work (4 years), elective courses in economics

Master of Science (Dipl. Engineer) with a major in Microbiology and minor in Bioprocessing; included extensive laboratory experience and elective economics coursework.