Experience

ADC Therapeutics

• Switzerland
• Biotechnology Research
• 200 - 300 Employee

• Toxicologist

  • May 2022 - Present



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Toxicologist

  • Sep 2020 - May 2022

  Was responsible for the pre-clinical safety strategy for projects in the Infectious disease and Immuno-oncology portfolios; including several T-cell engaging bispecific antibodies, and a small molecule immune agonist FIH package. Was Involved in assessing on-target off-tumour toxicity liabilities for projects in Immuno-oncology and for designing the toxicology plan for targets in solid tumour and myeloid tumour disease areas. Designed and managed the appropriate safety investigations, whether conducted internally or externally contracted. Provided related parts of the documents for regulatory submission, to support clinical trials. Show less



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pre clinical safety expert

  • Feb 2018 - Sep 2020

  Supported nanobody bispecific projects in Immunology and Inflammation and a cell replacement therapy along with other projects. Active member of the DART advisory group. Supported nanobody bispecific projects in Immunology and Inflammation and a cell replacement therapy along with other projects. Active member of the DART advisory group.



CSL

• Australia
• Biotechnology Research
• 700 & Above Employee

• Senior Toxicologist

  • Dec 2016 - Jan 2018

  Supported CSLs first phase III programme, supported several monoclonal antibody projects in development including reproductive toxicology strategy. Supported CSLs first phase III programme, supported several monoclonal antibody projects in development including reproductive toxicology strategy.



Horsley Toxicology consulting

• Consultant

  • 2012 - Dec 2016

  Strategic consulting in nonclinical drug development programs, toxicity study design and execution, report review, CRO evaluation and monitoring, preparation of nonclinical regulatory submission documents. Strategic consulting in nonclinical drug development programs, toxicity study design and execution, report review, CRO evaluation and monitoring, preparation of nonclinical regulatory submission documents.



AiCuris Anti-infective Cures AG

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Toxicologist

  • 2011 - 2012

  Responsible in project teams for developing and implementing the nonclinical safety strategy in support of clinical plans for the entire antiviral portfolio. Responsible for interpretation of toxicity issues arising and designing appropriate follow up studies, and for outsourcing all toxicology studies to CROs. Review, summarize, and interpret experimental data and prepare clear, concise reports. Responsible for authorship of relevant sections of regulatory documentation. Experience in due diligence activities. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Principal Scientist

  • Apr 2008 - Aug 2011

  Project Toxicologist, responsible for developing and implementing the nonclinical safety strategy in support of clinical plans for both small-molecules and biologics (monoclonal antibodies), and for writing relevant sections of regulatory submissions. Supported global project teams in the pain, internal medicine, regenerative medicine and allergy-and-respiratory therapeutic areas. Successful interactions with regulatory authorities in Europe and the USA to progress clinical plans into Phase II proof of concept studies. Also evaluated new targets to identify possible toxicity issues and supported those projects in their discovery phase. Previous responsibilities included Study Direction of general toxicity studies ranging from non-GLP dose toleration and investigative toxicity studies to the pivotal (GLP) subchronic and chronic toxicity studies, while mentoring junior study managers and maintaining an internal vehicle safety database. Also placed and monitored GLP studies outsourced to CROs. Show less



Vertex Pharmaceuticals

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior non clinical development scientist

  • 2006 - 2008

  Project Toxicologist, responsible for the design and monitoring of GLP and non-GLP nonclinical safety studies at CRO’s, initially to support IND filing. Principal focus was a next-generation antibiotic, and a second-generation HCV protease inhibitor. Other responsibilities were to provide specialist support in the design and monitoring of studies in the area of reproductive toxicology for all the development compounds, and to assist with early evaluation of toxicity for discovery compounds. Project Toxicologist, responsible for the design and monitoring of GLP and non-GLP nonclinical safety studies at CRO’s, initially to support IND filing. Principal focus was a next-generation antibiotic, and a second-generation HCV protease inhibitor. Other responsibilities were to provide specialist support in the design and monitoring of studies in the area of reproductive toxicology for all the development compounds, and to assist with early evaluation of toxicity for discovery compounds.



Envigo ++++

• United States
• Research
• 300 - 400 Employee

• Toxicologist

  • Oct 2003 - Oct 2006

  Served as Study Director for animal studies and related projects conducted in the Safety Assessment group. Responsibilities included design, conduct, interpretation and reporting of in vivo safety/toxicity study programmes, addressing general aspects of toxicity, as well as more specific investigative work related to issues arising from the screening studies. Main area of work was in the reproductive toxicology group conducting embryo-fetal toxicity studies in rodents and non-rodents, fertility and juvenile toxicity studies. Studies of this type were intended principally for Regulatory submission, and included supporting activities in formulation chemistry, bioanalysis/toxicokinetics and sometimes other specialisms, and were conducted to full GLP standards. The work required extensive communication with various sponsors, mainly from the pharmaceutical industry, relating to the various issues of study design and content, results and interpretation. Show less



NCTR

• Jefferson, AR, USA

• postdoc

  • 2002 - 2003

  Responsibilities included (a) examination of embryonic gene expression during neural tube closure in mice exposed to valproic acid, using gene expression microarrays; b) determination of biotin deficiency-induced malformations in mouse embryos using the Staples technique; and c) investigation of the anti-folic acid effects of exposure to methotrexate over 12-hour periods during gestation in mice, following which period an osmotic pump containing folinic acid was implanted into the mice to rescue the animals from the effects of methotrexate. Show less