Niels Adams - Consultant: Translational Sciences

Q: Where is Niels based?

Niels is based in Gauting, Germany .

Q: What languages does Niels speak?

Niels speaks the following languages: Danish (Native), English (Native), German (Advanced) .

Q: How many years of experience does Niels have?

Niels has at least 30 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 2 years and 6 months . Note that Niels may not have shared all experience and actually has more experience.

Q: What is Niels's latest experience?

Niels's most recent position is Consultant: Translational Sciences at Large Pharma .

Q: What companies has Niels worked for in recent years?

In recent years, Niels has worked for Large Pharma , Mid-Size Biotech , Global Specialty Laboratory , PSI CRO GmbH , and Freelance Consultancy .

Q: Which industries is Niels most experienced in?

Niels is most experienced in industries like Biotechnology , Healthcare , and Pharmaceutical . Niels also has some experience in Education .

Q: Which business areas is Niels most experienced in?

Niels is most experienced in business areas like Research and Development (R&D) , Quality Assurance (QA) , and Operations . Niels also has some experience in Product Development , Marketing , and Strategy and Planning .

Q: Which industries has Niels worked in recently?

Niels has recently worked in industries like Biotechnology , Healthcare , and Pharmaceutical .

Q: Which business areas has Niels worked in recently?

Niels has recently worked in business areas like Quality Assurance (QA) , Marketing , and Product Development .

Recommended expert

Gauting, Germany

Experience

Dec 2023 - Dec 2024

1 year 1 month

Germany

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

Aug 2023 - Present

2 years 7 months

Germany

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.

Jan 2022 - Present

4 years 2 months

Consultant: Business Development Strategy

Global Specialty Laboratory

Business development strategy
Proposal process and strategy

Feb 2018 - Apr 2023

5 years 3 months

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

Sep 2016 - Mar 2017

7 months

Vienna, Austria

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

Dec 2011 - Aug 2016

4 years 9 months

Munich, 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 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

Sep 2011 - Jun 2023

11 years 10 months

Munich, Germany

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

Jan 2009 - Aug 2011

2 years 8 months

Oxford, 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 months

Cambridge, 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 years

New York, United States

Senior Staff Scientist

Regeneron Pharmaceuticals, Inc.

Performed preclinical target discovery and validation studies

Jul 1999 - Oct 2001

2 years 4 months

New York, United States

Postdoctoral Associate/Research Associate

Rockefeller University

Conducted research in developmental neurobiology

Oct 1995 - Jun 1999

3 years 9 months

London, United Kingdom

Wellcome Postdoctoral Research Fellow

Kings College London

Conducted research in developmental neurobiology

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

Danish

Native

English

Native

German

Advanced

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

Profile

Created

December 2025

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Niels based?

Niels is based in Gauting, Germany.

What languages does Niels speak?

Niels speaks the following languages: Danish (Native), English (Native), German (Advanced).

How many years of experience does Niels have?

Niels has at least 30 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 2 years and 6 months. Note that Niels may not have shared all experience and actually has more experience.

What roles would Niels be best suited for?

Based on recent experience, Niels would be well-suited for roles such as: Consultant: Translational Sciences, Consultant: Clinical Operations, Consultant: Business Development Strategy.

What is Niels's latest experience?

Niels's most recent position is Consultant: Translational Sciences at Large Pharma.

What companies has Niels worked for in recent years?

In recent years, Niels has worked for Large Pharma, Mid-Size Biotech, Global Specialty Laboratory, PSI CRO GmbH, and Freelance Consultancy.

Which industries is Niels most experienced in?

Niels is most experienced in industries like Biotechnology, Healthcare, and Pharmaceutical. Niels also has some experience in Education.

Which business areas is Niels most experienced in?

Niels is most experienced in business areas like Research and Development (R&D), Quality Assurance (QA), and Operations. Niels also has some experience in Product Development, Marketing, and Strategy and Planning.

Which industries has Niels worked in recently?

Niels has recently worked in industries like Biotechnology, Healthcare, and Pharmaceutical.

Which business areas has Niels worked in recently?

Niels has recently worked in business areas like Quality Assurance (QA), Marketing, and Product Development.

What is Niels's education?

Niels holds a Doctorate in Anatomy and Physiology from Oxford University and a Bachelor in Biology with European Studies (German) from Sussex University.

Does Niels have any certificates?

Niels has 1 certificate: ISO15189.

What is the availability of Niels?

The availability of Niels needs to be confirmed.

What is the rate of Niels?

Niels's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.