Niels (C.) Adams-Consultant: Translational Sciences
Check rate
Experience
Consultant: Translational Sciences
Large Pharma
- Authoring biomarker planning documents, biomarker manuals, research and development reports
- Review of clinical trial and vendors’ biomarker reports
- Development of standard operating procedures and interdepartmental training materials
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 paediatric 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 maximise efficient use of limited participant samples in paediatric 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, vendor oversight processes, including risk mitigation.
Consultant: Business Development Strategy
Global Specialty Laboratory
- Business development strategy
- Proposal process and strategy
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 in proposals
- Served as primary point of contact for sponsors during study setup and execution, acting as escalation contact
- Developed tools for departmental oversight, reward vs cost of revenue analysis, KPI monitoring and external vendor cost management
Senior Director of Science
Austrianni GmbH
- Led preclinical development including target validation, screening and selection of antibody candidates, in vitro, in vivo and non-human primate testing
- Managed design and development of high throughput screening assays (SPR, ECL, ELISA, cellular assays) for selection and validation of therapeutic antibody candidates for tuberculosis
- Oversaw outsourcing to CROs
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 achieved ISO15189 accreditation
Qualified and validated equipment and computer systems
Acted as designated qualified person responsible for clinical trials as central laboratory (providing CDx assays) under GCP & GLP for Invivoscribe Inc
Led external audits and supplier management and managed IP enforcement
Managed commercial launch and EU billing strategies
Developed, validated and brought to market 3 CE IVD (under ISO 13485) and 2 RUO NGS clonality and minimal residual disease diagnostic assays for Invivoscribe Inc
Freelance Consultancy
- CRO assessment and management
- Process development
- LIMS design and development
- New technology assessment and implementation
- Supervision of in vivo models for preclinical validation
- Medical device development, including wearables
- ISO15189 & ISO17020 accreditation support
- IVDR readiness
- Diagnostic laboratory acquisition
- Laboratory business development and marketing strategy
- New lab setup
Head of Services and Development
MRC Harwell
- Managed transgenic mouse services including generation, genotyping, phenotyping, pathology and bioinformatics
Manager of the Mouse Genetics Programme
Wellcome Trust Sanger Institute
- Managed transgenic mouse services including generation, genotyping, phenotyping, gene expression, pathology and bioinformatics
Senior Staff Scientist
Regeneron Pharmaceuticals, Inc.
- Performed preclinical target discovery and validation studies
Postdoctoral Associate/Research Associate
Rockefeller University
- Conducted research in developmental neurobiology
Wellcome Postdoctoral Research Fellow
Kings College London
- Conducted research in developmental neurobiology
Industry experience
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Experienced in Biotechnology, Healthcare, Pharmaceutical, and Education.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Research and Development, Quality Assurance, Operations, Product Development, Marketing, and Project Management.
Summary
Owner, Adams Consulting Services GmbH 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 cell and other ATMPs. Hands on knowledge of ISO15189/CAP/CLIA lab accreditation) molecular oncology).
Languages
Education
Oxford University
DPhil in Anatomy and Physiology · Anatomy and Physiology · Oxford, United Kingdom
Sussex University
BSc Biology with European Studies (German) · Biology with European Studies (German) · United Kingdom
Certifications & licenses
ISO15189
Statistics
Experience
Global experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Niels is based in Gauting, Germany.
Niels speaks the following languages: Danish (Native), English (Native), German (Advanced).
Niels has at least 31 years of experience. During this time, Niels has worked in at least 11 different roles and for 12 different companies. The average length of individual experience is 3 years and 7 months. Note that Niels may not have shared all experience and actually has more experience.
Based on recent experience, Niels would be well-suited for roles such as: Consultant: Translational Sciences, Consultant: Clinical Operations, Consultant: Business Development Strategy.
Niels's most recent position is Consultant: Translational Sciences at Large Pharma.
In recent years, Niels has worked for Large Pharma, Mid-Size Biotech, Global Specialty Laboratory, PSI CRO GmbH, and Freelance Consultancy.
Niels is most experienced in industries like Biotechnology, Healthcare, and Pharmaceutical. Niels also has some experience in Education.
Niels is most experienced in business areas like Research and Development, Quality Assurance, and Operations. Niels also has some experience in Product Development, Marketing, and Strategy.
Niels has recently worked in industries like Biotechnology, Healthcare, and Pharmaceutical.
Niels has recently worked in business areas like Quality Assurance, Marketing, and Product Development.
Niels holds a Doctorate in Anatomy and Physiology from Oxford University and a Bachelor in Biology with European Studies (German) from Sussex University.
Niels has 1 certificate: ISO15189.
The availability of Niels needs to be confirmed.
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Calculated based on our freelancers’ daily rates as of 7 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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