Chief Executive Officer
Current
Mar 2020 - Present
Who is Nicole Baker Phd? Overview
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Quick answer
Nicole Baker Phd is listed as CEO at biologit at biologit, based in County Dublin, Ireland. AeroLeads shows a work email signal at bioclinica.com and a matched LinkedIn profile for Nicole Baker Phd.
Nicole Baker Phd previously worked as Chief Executive Officer at Biologit and EEA QPPV and RPPV at Qppv. Nicole Baker Phd holds Executive Development, Michael Smurfit Graduate Business School, Strategic Growth - Biotech And Pharma Industry from University College Dublin.
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*@bioclinica.com
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Profile bio
About Nicole Baker Phd
Nicole Baker is the CEO of Biologit, a pioneering technology company specialising in Artificial Intelligence for Active Safety Surveillance. As an Immunologist and Pharmacovigilance Professional, Nicole blends innovative thinking with a profound scientific understanding and extensive global expertise in Medical and Regulatory Affairs, Pharmacovigilance, and Clinical Development.With over 25 years of experience, Nicole has held leadership roles across diverse sectors, including Academia, the Pharmaceutical Industry, Regulatory Authorities, Clinical Research Organisations, and Start-up. She has successfully managed global, multi-disciplinary teams throughout the entire product life-cycle, from pre-clinical stages to post-marketing. Nicole's career highlights include pivotal roles such as EEA QPPV and RPPV in Clinical Trials, and overseeing research and commercial budgets exceeding 100 million.
Listed skills include Pharmacovigilance, Regulatory Affairs, Immunology, Pharmaceutical Industry, and 40 others.
Current workplace
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17 roles · 33 years
Nicole Baker Phd work experience
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May 2019 - Present
Commercial Lead
biologit is an ADAPT Centre research team working with Professor Lucy Hederman within Trinity College Dublin, School of Computer Sciences & Statistics. Funded by Enterprise Ireland Commercialisation Fund.
Mar 2020 - May 2021
New Frontiers Entrepreneur Development Programme Phase 2 Participant
Developing Artificial Intelligence solutions for Clinical Safety and Pharmacovigilance/Drug Safety.
May 2019 - Nov 2019
Eea Qppv, Head Of Global Pharmacovigilance
Held the interim position of Head of Global Regulatory Affairs for 6 months.Responsible for Medical and Scientific Information.Reporting to the Board of Directors, responsible for budget and management of department.Providing strategic, operational and scientific leadership and fulfilling the responsibilities of EEA QPPV. Set up the Dublin office: hired, on-boarded and developed internal and external teams. Successfully transitioned pharmacovigilance activities to a new service provider. Successfully implemented new versions and automated the safety database. Implemented and developed quality systems for pharmacovigilance. Integral part of due diligence for new business. Responsible for the safety sections of marketing authorisation applications.
Jul 2017 - May 2019
Eea Qppv, Global Director Drug Safety And Risk Management
Fulfilled the role of EEA QPPV and RP for Pharmacovigilance in Clinical Trials.Set up and implemented pharmacovigilance systems.Responsible for the safety sections of successful new marketing authorisations in the US and EMA.Provided strategic, operational and scientific leadership for clinical, post-marketing and QPPV projects, covering multinational companies with products at various stages of their life-cycle.Successfully actioned Corrective Actions Preventive Actions (CAPAs) as part of an EMA Good Clinical Practice (GCP) inspection and MHRA pharmacovigilance inspection.Integral part of business development services related to drug safety, pharmacovigilance, life sciences consulting and clinical trials, bringing new business and growing existing ones.
Apr 2016 - Jul 2017
Eea Qppv, Associate Director Integrated Safety Services
Fulfilled the role of EEA QPPV.Set up and implemented pharmacovigilance systems.Supported clients on diversion and acquisition of new products.Successfully actioned and implemented CAPAs as part of an EMA GCP inspection and MHRA pharmacovigilance inspection.Provided strategy, leadership and operational oversight/input for complex pharmacovigilance services.Won new business in drug safety, pharmacovigilance, life sciences consulting and clinical trials.
Mar 2015 - Apr 2016
Eea Qppv, Associate Director Customer Delivery Europe
Fulfilled the role of EEA QPPV and RP for Pharmacovigilance in Clinical Trials.Conducted due diligence, set up and implemented pharmacovigilance systems.Supported clients on diversion and acquisition of new products.Responsible for the safety sections of successful new marketing authorisations in the US, EMA and Brazil.Successfully actioned and implemented CAPAs as part of an EMA GCP inspection and FDA pharmacovigilance inspection.Provided strategic, operational and scientific leadership for clinical, post-marketing and QPPV projects, covering multinational companies with products at various stages of their life-cycle.Won new business related to drug safety, pharmacovigilance, life sciences consulting and clinical trials, and further developed existing ones.
Aug 2013 - Mar 2015
Pharmacovigilance Scientist
Supported the set-up of the Dublin office, on-boarded, trained internal teams, set up and implemented pharmacovigilance systems.Lead scientist responsible for cardiology, metabolic, immunology, oncology and inflammation portfolio, supported the EEA QPPV and the PSMF maintenance.Participated in a MHRA/HPRA inspection, and interacted with competent authorities.Responsible for the maintenance of company core safety information and labels, generating and reviewing aggregate reports, signal detection outputs and reports, risk management, literature review, quality review of individual case safety reports, and implementation and maintenance of safety data exchange agreements.
Mar 2012 - Aug 2013
Research Fellow And Project Manager
Designed and performed laboratory experiments for the project: Immunomodulatory properties of Helicobacter pylori. Management of project and budget.Teaching and supervising students and junior staff.
Feb 2011 - Mar 2012
Safety And Efficacy Assessor
Assessment of safety and efficacy aspects of national, decentralised and mutual recognition applications for new immunological products, as well as renewals and variations.Responsible for assessing aggregate reports and risk management plans.Participation in decision making meetings related to applications for immunologicals at EU level.
Jan 2009 - Jan 2010
Research Fellow And Project Manager
Designed and performed laboratory experiments for the projects: (A) Lipoxin as a therapeutic candidate for the treatment of Rheumatoid Arthritis. (B) Lipoxin prevents angiogenesis and proliferation in endothelial cells. (C) Testing and validating lipoxin stable analogues for further use in vivo and in vitro. (D) Novel therapies for diabetic nephropathy. Management of project and budget.Teaching and supervising students and junior staff.
May 2007 - Jan 2009
Medical Scientist
Provided a nationwide transplant immunology service for solid organ transplantation, including HLA typing, crossmatching donors and recipients for solid organ transplants.
Jan 2007 - May 2007
Research Fellow And Project Manager
Designed and performed laboratory experiments for the projects: A) Animal models for the development of an effective nasal vaccine for Tuberculosis, HIV and Malaria. (B) Animal models using dentritic cell adoptive transfer for the treatment of Rheumatoid Arthritis and Multiple Sclerosis. Management of project and budget.Teaching and supervising students and junior staff.
Jan 2005 - Jan 2007
Research Assistant And Laboratory Manager
Designed and performed laboratory experiments for the projects: (A) Serum IgM deficiency leads to increased susceptibility to Glomerulunephritis. (B) Serum IgM is important for B cell positive selection. (C) Production and characterization of anti-DNA antibodies and its role in Glomerulunephritis. (D) Study of B cells on patients with Lupus or Rheumatoid Arthritis being treated with anti-CD20 or anti-TNF antibodies.Management of project and budget.Teaching and supervising students and junior staff.Maintenance of equipment and overall run of the laboratory.
May 2000 - Jan 2005
Research Assistant
Designed and performed laboratory experiments for the project: The role of regulatory T cells in animal models of Arthritis.Management of project and budget.Teaching and supervising students and junior staff.
Sep 1999 - Jan 2000
1994 - 1999
~5 yrs
4 education records
Nicole Baker Phd education
Executive Development, Michael Smurfit Graduate Business School, Strategic Growth - Biotech And Pharma Industry
University College Dublin
Doctor Of Philosophy - Phd, Medicine - Rheumatology
University Of London
Master'S Degree, Biomedical Sciences - Immunology
Usp - Universidade De São Paulo
Bachelor'S Degree, Biological Sciences - General
Universidade Ibirapuera
FAQ
Frequently asked questions about Nicole Baker Phd
Quick answers generated from the profile data available on this page.
What company does Nicole Baker Phd work for?
Nicole Baker Phd works for biologit.
What is Nicole Baker Phd's role at biologit?
Nicole Baker Phd is listed as CEO at biologit at biologit.
What is Nicole Baker Phd's email address?
AeroLeads has found 1 work email signal at @bioclinica.com for Nicole Baker Phd at biologit.
Where is Nicole Baker Phd based?
Nicole Baker Phd is based in County Dublin, Ireland while working with biologit.
What companies has Nicole Baker Phd worked for?
Nicole Baker Phd has worked for Biologit, Qppv, Adapt Centre, Trinity College Dublin, Enterprise Ireland, and Besins Healthcare.
How can I contact Nicole Baker Phd?
You can use AeroLeads to view verified contact signals for Nicole Baker Phd at biologit, including work email, phone, and LinkedIn data when available.
What schools did Nicole Baker Phd attend?
Nicole Baker Phd holds Executive Development, Michael Smurfit Graduate Business School, Strategic Growth - Biotech And Pharma Industry from University College Dublin.
What skills is Nicole Baker Phd known for?
Nicole Baker Phd is listed with skills including Pharmacovigilance, Regulatory Affairs, Immunology, Pharmaceutical Industry, Clinical Trials, Pharmacology, Project Management, and Vaccines.
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