Niels (C.) A.
Consultant: Translational Sciences
Experience
Dec 2023 - Dec 2024
1 year 1 monthGermany
Consultant: Translational Sciences
Large Pharma
- Authoring biomarker planning documents, biomarker manuals and research and development reports
- Review of clinical trial and vendors’ biomarker reports
- Development of standard operating procedures and interdepartmental training materials
Aug 2023 - Present
2 years 5 monthsGermany
Consultant: Clinical Operations
Mid-Size Biotech
- Phase I, II & pivotal studies in EU, US & APAC in B cell lymphomas (including DLBCL, ALL) and inflammatory diseases (SLE, MS, etc.) for both adults and pediatric populations
- Coaching clinical teams to ensure compliance with national and international standards (CTR, ICH-GCP, GDPR, IVDR, GLP, CDx, etc.)
- Delivery of clinical trial protocols with a focus on patient centricity and welfare
- Lead vendor selection, assessment, RFPs, contracting, trial set up and management for CAR T and medical device trials (CROs, central labs, imaging, CTAs, etc.)
- Define biomarker strategies to maximize efficient use of limited participant samples in pediatric studies
- Facilitate translational sciences to progress pre-clinical biomarker concepts to clinical trials for oncology and inflammatory diseases (selection, development and validation of biomarker assays including immunogenicity, PK & PD strategies)
- Guidance and document generation during regulatory authorities’ interaction (e.g., CTIS) process
- Provide strategic input for senior team to ensure sustainable (efficient) processes are used for clinical development
- Vendor qualification audits
- Developed SOPs for vendor audits (CROs, central labs, imaging, eCOA, etc.), qualification, oversight, KPI monitoring and vendor oversight processes, including risk mitigation.
Jan 2022 - Present
4 yearsConsultant: Business Development Strategy
Global Specialty Laboratory
- Business development strategy
- Proposal process and strategy
Feb 2018 - Apr 2023
5 years 3 monthsMunich, Germany
Head of Clinical Trial Support
PSI CRO GmbH
- Managed over 100 Phase II & III trials in oncology, infectious, inflammatory and rare diseases worldwide
- Head of department for vendor management, laboratory support services, supply chain management (CMOs), eCOA, drug (IMP) depots, equipment supply and import/export
- Defined and presented laboratory related strategy to clients and managed laboratory strategy and budgets included in all proposals
- Served as primary point of contact and escalation contact for sponsors during study setup and execution
- Developed tools for departmental oversight, management (reward vs cost of revenue), KPI monitoring and external vendor cost tracking
Sep 2016 - Mar 2017
7 monthsVienna, Austria
Senior Director of Science
Austrianni GmbH
- Managed preclinical development including target validation, screening and selection of antibody candidates
- Oversaw in vitro, in vivo and non-human primate preclinical testing
- Designed and developed high-throughput screening assays (SPR, ECL, ELISA, cellular assays) for the selection and validation of antibody drug candidates for tuberculosis
- Managed outsourcing to CROs
Dec 2011 - Aug 2016
4 years 9 monthsMunich, Germany
Director of Operations
LabPMM GmbH
- Set up, equipped and recruited staff for the laboratory
- Validated and verified assays (qPCR, PCR, NGS & Sanger sequencing, haematology)
- Developed the quality management system and gained ISO15189 accreditation
- Qualified and validated equipment and computer systems
- Acted as designated qualified person for clinical trials as central laboratory under GCP & GLP for Invivoscribe Inc
- Led external audits and supplier management; managed IP enforcement
- Responsible for commercial launch, including EU billing strategies
- Developed, validated and launched three CE IVD assays (under ISO 13485) and two RUO NGS clonality and minimal residual disease diagnostic assays for Invivoscribe Inc
Sep 2011 - Jun 2023
11 years 10 monthsMunich, Germany
Freelance Consultancy
Freelance Consultancy
- Assessed and managed CROs
- Developed processes and designed and developed LIMS
- Assessed and implemented new technologies
- Supervised in vivo models for preclinical validation
- Developed medical devices including wearables
- Supported ISO15189 & ISO17020 accreditation and IVDR readiness
- Led diagnostic laboratory acquisitions and new lab setup
- Defined laboratory business development and marketing strategies
Jan 2009 - Aug 2011
2 years 8 monthsOxford, United Kingdom
Head of Services and Development
MRC Harwell
- Managed transgenic mouse services including generation, genotyping, phenotyping, pathology and bioinformatics
Nov 2005 - Dec 2008
3 years 2 monthsCambridge, United Kingdom
Manager of the Mouse Genetics Programme
Wellcome Trust Sanger Institute
- Managed transgenic mouse services including generation, genotyping, phenotyping, gene expression, pathology and bioinformatics
Nov 2001 - Oct 2005
4 yearsNew York, United States
Senior Staff Scientist
Regeneron Pharmaceuticals, Inc.
- Conducted preclinical target discovery and validation
Jul 1999 - Oct 2001
2 years 4 monthsNew York, United States
Postdoctoral Associate/Research Associate
Rockefeller University
- Researched developmental neurobiology
Oct 1995 - Jun 1999
3 years 9 monthsLondon, United Kingdom
Wellcome Postdoctoral Research Fellow
Kings College London
- Researched developmental neurobiology
Summary
Owner of Adams Consulting Services GmbH in Munich, Germany. Scientist with management experience spanning target discovery, preclinical development, diagnostic labs and Phase I-III clinical trials (oncology, infectious, inflammatory and rare diseases). Passion for streamlining focused diagnosis for oncology. Experience with CAR T cells and other ATMPs. Hands-on knowledge of ISO15189/CAP/CLIA lab accreditation and molecular oncology.
Languages
Danish
NativeEnglish
NativeGerman
AdvancedEducation
Sussex University
BSc · Biology with European Studies (German) · Brighton and Hove, United Kingdom
Oxford University
DPhil · Anatomy and Physiology · Oxford, United Kingdom
Certifications & licenses
ISO15189 Accreditation
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