Company profile
3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of (bio-)pharmaceuticals and diagnostics.
Our team of experts covers the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition, we provide out-licensing and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups.

Job description
For the various projects that we are running for our clients, we are looking for a consultant non- clinical development to join our team of consultants. The ideal candidate has a background in ADME
(preferred) and Toxicology and is able to look beyond his or her borders and has an ambition to grow in a young and growing organization. Training and/or coaching will be provided in specific
areas if needed.

Minimal requirements

• PhD or equivalent, or MSc degree in Life Sciences, with experience in drug development or
  similar field
• At least 3 years of experience as an ADME study director, non-clinical project manager or
  other drug development role
• Communication skills: good oral, writing and presentation skills
• Personality skills: pro-active, team player, results-oriented, can-do mentality and ability to put
  yourself in the position of our clients
• Experience in a number of the following areas and roles (not all required):
• Experience in conducting or monitoring drug metabolism studies
• Experience in designing, monitoring or conducting safety (toxicology) studies at CRO’s and
  analyzing/presenting data
• Knowledge of and experience in global regulatory requirements for the development and
  registration of new medicinal products (chemical entities and/or biologicals)
• Experience in drafting and reviewing biocompatibility and/or safety assessments,
  researching literature and toxicology database resources, and summarizing information
• Experience in writing and/or reviewing documents for specific global regulatory purposes,
  e.g. investigators’ brochures, IMPD, (non-)clinical dossier (eCTD), etc.
• Understanding of Good Laboratory Practice (GLP) regulations
• Project coordination and project team participation

Interested?

Send your CV and short motivation letter to Nina Lemmers-van Erp at nina@3d- pxc.com. For more information, you can also contact her at +31 (0)13 53 482 72

Company profile

3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and the Pivot Park in Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts aims to cover the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition, we provide out-licensing and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups.

Job description

For the development of the various projects we run for our clients, we are looking for a regulatory affairs expert to join our team of regulatory affairs consultants. The ideal candidate is able to look beyond his or her borders and has an ambition to grow in a young and growing organization. Coaching will be provided in specific areas if needed. 

Minimal requirements 

• Master degree in Life Sciences, e.g. Biomedical Sciences, Medical Biology, Pharmacy, Chemistry
• At least 3 years of experience in a regulatory affairs role
• Communication skills: good oral, writing and presentation skills 
• Personality skills: pro-active, team player, entrepreneurial, can work under time pressure, can-do mentality and ability to put yourself in the position of our clients. 

Experience in a number of the following areas and roles (not all required):

• Knowledge of and experience in global regulatory requirements for the development and registration of new medicinal products (chemical entities and biologicals) 
• Experience in preparation and submission of clinical trial applications 
• Experience in preparing regulatory strategies for all stages of drug development 
• Experience in writing and/or reviewing documents for specific global regulatory purposes, e.g. investigators’ brochures, nonclinical and clinical dossier (eCTD) overviews/summaries, DSURs/PSURs, pre-IND/End-of-Phase 2/scientific advice briefing/background packages, target product profiles, product information/labeling documents, risk management plans (RMPs), agency response documents, etc. .
• Experience in preparation and submission of scientific advice and orphan designation applications and pediatric investigational plans (PIPs) 
• Experience in companion diagnostic regulations
• Experience with additional Risk Minimization Measures
• Experience in interactions and meetings with regulatory agencies 
• Project coordination and project team participation 
• Demonstrated competency and experience in all stages of drug development within the pharmaceutical industry 

Interested? 

Send your CV and short motivation letter to Nina Lemmers-van Erp at nina@3d- pxc.com. For more information, you can also contact her at +31 (0)13 53 482 72 

Company profile

3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition, we provide out-licensing and interim management support. Our clients are innovative biotech start-ups as well as leading big pharma companies.

Job description 

Our CMC team, specialized in delivering CMC support to pharmaceutical companies and biotech industry, is seeking to expand with a Director CMC that will lead our team of CMC experts, and work as a consultant on customer programs. Depending on the customer project you may be working on any aspect of CMC development for a biological (including ATMP) or small molecule; both in a managing role, and as a Subject Matter Expert. Thus, your experiences in early and late stage process development, including formulation development, analytical assay or method development, CMC regulatory trajectories, manufacturing of Drug Substance/API or Drug Product, Technology Transfers, and selection and management of CROs and CMOs are all key assets for this role. Reviewing development and validation protocols and reports, and writing documents for regulatory purposes, may all be part of the role.

The Director CMC will lead a team of 5-10 consultants in the CMC area, including coaching (especially the more junior) consultants in their roles in customer programs as well as target setting for the individual reports and appraisal of the consultants. The Director CMC has responsibility for the sales target for the CMC team and support in business development will be part of your role. The Director CMC will be part of the extended management team within 3D-PharmXchange.

Requirements and qualifications

• PhD (preferred) or MSc in the area of Bio (process) technology, Chemistry, Analytical Chemistry, Pharmaceutical Sciences.
• Demonstrated competency, experience, and knowledge in CMC development and manufacturing requirements from early to late phase within the pharmaceutical industry.
• At least 5 years of experience in a comparable position and/or work environment is required.
• People management experience is required
• Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality, organizational sensitivity, stakeholder management, people management.
• Essential communication skills: fluency in English, oral, writing and presentation skills.
• Specific hands-on experience in one or multiple of the following focus areas is desired: process chemistry, formulation development; upstream processing (of Biologicals – fermentation; cell culture); analytical assay or method development. 
• Demonstrated competency in writing and reviewing CMC regulatory submission documentation (IND/IMPD/NDA/BLA) and answering any possible CMC regulatory questions.
• Network in (local) biotech industry.
• Thorough experience in project management and project team participation.
• Experience with CRO and/ or CDMO selection and management is desired

Interested? Send your CV and short motivation letter to Nina Lemmers-van Erp, at nina@3d-pxc.com 

Acquisition is not appreciated!

Company profile

3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, CMC, regulatory affairs, and project management. In addition, we provide out-licensing and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups.

Job description

For the various projects that we are running for our clients, we are looking for a consultant Clinical Development, able to provide scientific direction (ie, clinical strategy/science input) in support of clinical programs and/or studies for the development of investigational (bio)pharmaceutical compounds.

 Your responsibilities include:

• Developing the clinical development strategy of an investigational compound, including the definition of milestones and Go/No-go criteria
• Translating biomarker data to decisive proof-of-concept studies
• Development of clinical study designs
• Support (interim) statistical analysis plan development
• (Support of) interpretation of data and report writing
• (Support) development of new endpoints
• (Support) development of essential documents e.g., Clinical Trial Protocol, IB etc.
• Clinical representative in Scientific Advice meetings at regulatory authorities (EMA, FDA)
• Clinical representative in a cross functional collaborative environment
• An equal and expert discussion partner in the communication with KOL’s
• Coordinating of project management activities to ensure timely, uniform and quality delivery of the services provided to our clients

 Requirements & qualifications

• Relevant academic background in biomedical field, preferably PhD
• Experience with (early) clinical drug development
• A minimum of 5 years’ experience in the biotech or pharmaceutical industry. Experience in innovative small biotech is a pre.
• Experience with developing clinical strategy, including development of (innovative) clinical trial designs and clinical development plans, preferably in a variety of clinical programs
• Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines.
• Experience with Scientific Advice meetings at EMA or FDA is a pre.
• Sense of milestones, timelines & budgets
• Excellent writing skills (English), particularly with respect to clinical protocol and reports
• Evidence of good scientific and clinical judgment, flexibility, and resilience
• Ability to work independently and in a team environment
• Capable of effectively managing multiple deadlines and projects
• Ability to adapt to rapidly evolving situations and needs
• Strong commitment to delivering high-quality work
• Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality, and ability to put yourself in the position of our clients

Interested? 

Send your CV and short motivation letter to Nina Lemmers-van Erp at nina@3d- pxc.com. For more information, you can also contact her at +31 (0)13 53 482 72 

Company profile 

 3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition, we provide out-licensing and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups.

Job description

For the various projects that we are running for our clients, we are looking for a consultant Clinical Development, able to provide clinical operations expertise in support of clinical programs and/or studies for the development of investigational (bio)pharmaceutical compounds.

 Your responsibilities include:

• Act as primary counterpart for vendor(s); act as sponsor representative being ‘spider in the web’ on behalf of the sponsor and responsible for vendor oversight
• Development and management of study budget, study planning, and study metrics
• Provide input on essential documents, including Clinical Trial Protocol, Informed Consent, etc.
• (Support) execution of clinical trials according to timelines and within budget
• (Support) site relationships, clinical trial registration, eCRF development, data collection (ensuring completeness, accuracy, and consistency), protocol issue management, newsletter, insurance etc.
• (Support) organization investigator meetings, DSMB meetings, advisory board meetings, KOL meetings, advisory board meetings, KOL meertings etc.
• (Support) vendor selection process
• (Support) vendor management
• Being a clinical operations representative in a cross functional collaborative environment
• Coordinating of project management activities to ensure timely, uniform and quality delivery of the services provided to our clients

 Requirements and qualifications

• Relevant academic background in biomedical field
• A minimum of 5 year experience in the biotech or pharmaceutical industry. Experience in innovative small biotech is a pre.
• Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines.
• Evidence of being able to create, execute and proactively manage clinical processes to ensure quality, timeline, resources, and budget goals are met
• Experience as clinical trial lead
• Flexible and resilient
• Ability to work independently and in a team environment
• Capable of effectively managing multiple deadlines and projects
• Ability to adapt to rapidly evolving situations and needs
• Strong commitment to delivering high-quality work
• Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality, and ability to put yourself in the position of our clients
• Strong Excel skills

Interested? Send your CV and short motivation letter to Nina Lemmers-van Erp, at nina@3d-pxc.com 

Acquisition is not appreciated!