Carolin Schramm

Nonclinical Safety Expert / Distinguished Scientist @ Sanofi

About

Pharmaceutical Toxicologist with more than 15 years’ drug discovery and development experience. Small molecule and biologics drug safety assessment. Non-clinical safety lead on global drug project teams (stakeholder management, risk/impact assessment, delivery of large scale and complex projects to time and budget). Comprehensive knowledge of pre-clinical submission documentation. Outsourcing experience (CROs and academic collaborations). Special interest in Discovery and Investigative Toxicology and problem solving. Currently co-lead of the BTS Mechanistic and Discovery Toxicology Subsection. Member of the British Toxicology Society Scientific Subcommittee. UCB Safety strategy lead for protein degraders (PROTACs, molecular glues). Experience in the following therapy areas: oncology, neuroscience, bone /fibrosis, immunology and cardiovascular / GI.

Country

City

United Kingdom

Industry

Pharmaceuticals

Skill

Toxicology, Life Sciences, Drug Development, Pharmaceutical Industry, Drug Discovery, Cell, Clinical Development, Regulatory Submissions, Pharmacology, Genomics, Cancer Research, CRO, GLP, GCP, Oncology, Lifesciences, In Vivo, In Vitro, Biomarkers, Biotechnology

Experience

Nonclinical Safety Expert / Distinguished Scientist

Sanofi

2023-5 - Present · 3 yrs 5 mos

Scientific Advisor

Ignota Labs

2023-1 - Present · 3 yrs 9 mos

Member BTS Scientific Committee

British Toxicology Society (BTS)

2018-4 - 2024-6 · 6 yrs 3 mos

Co-chair of the BTS Mechanistic and Discovery Toxicology Speciality Section

British Toxicology Society (BTS)

2018-4 - 2024-6 · 6 yrs 3 mos

Non-clinical Safety Lead, Associate Director Toxicology

UCB

2017-12 - 2023-4 · 5 yrs 5 mos

Slough, United Kingdom

Preclinical project lead for global drug project teams (new chemical and biological entities; new modalities). Safety strategy lead for protein degraders. Innovative and tailored de-risking and optimisation of new experimental medicines. Supporting neuroscience, immunology and bone/fibrosis therapy area projects.

Toxicologist

Nerudia

2016-2 - 2017-10 · 1 yr 9 mos

Speke, Liverpool

Provision of toxicology expertise for medicinal and consumer nicotine replacement products. Toxicological assessment of nicotine delivery systems. Emissions toxicology for heated e-liquids/vapors. Product formulation development. TPD notifications. Permitted daily exposure assessment for manufacturing facilities. Acceptable daily intake calculations. Toxicology consulting.

Regulatory Submissions Expert (Pre-clinical Safety)

AstraZeneca

2013-9 - 2016-1 · 2 yrs 5 mos

Alderley Park, Macclesfield

Preparation of pre-clinical toxicology dossiers for clinical trial applications (Europe, US and China); INDs, MAs, IBs, CTDs, ASEAN; Carcinogenicity assessment documents (CAD); Submissions quality optimisation and standardisation; Study report review; Submission readiness of documents; IT tools;

Project Toxicologist (Pre-clinical Safety)

AstraZeneca

2007-6 - 2013-9 · 6 yrs 4 mos

Alderley Park, Macclesfield

Project management, design of safety packages, compound optimisation, toxicological data interpretation. Oncology and cardiovascular/GI therapy area support.