Careers at
3D-PharmXchange
No drug is developed by a single person
We understand that it takes teamwork and perseverance to realize something as big as bringing a new pharmaceutical to market. The 3D team works hard with room to laugh and is always looking to expand. If you are interested in 3D-PharmXchange, we invite you to contact us. You are always welcome to visit one of our offices for a coffee and discussion regarding our opportunities.
A Great Team & Atmosphere
At 3D-PharmXchange, you work with an experienced and dedicated team of professionals. Serious business with an informal way of working and room for a few laughs.
We offer a challenging job in an international environment, working for top entrepreneurs and big pharma. You will be working in a very dynamic, young, and growing team and have the freedom to shape your work. Although 3D-PharmXchange is well-known as an experienced partner in drug development, this doesn’t mean it is all about business. Our main aim is to centralize and empower our consultants. Not only professionally but also informally.
We Are Currently Looking For
Join our team of Dedicated Drug Development experts today.
3D-PharmXchange is interested in high-level experts in all key drug development disciplines. Our colleagues have an extensive and proven track record within companies developing innovative drugs (small molecules/biologicals/novel therapies), with a focus on early-stage drug development. Next to the open positions, be reminded that we also appreciate open applications and are always eager to discuss future collaboration.
Vacancy : Consultant Regulatory Affairs
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?
Please attach your CV to our contact form!
Vacancy : (Senior) Consultant Clinical Operations
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
We are looking for a clinical operational expert who can support our (small) biotech clients with the execution/oversight of their clinical studies and/or programs, and who is interested to develop towards a (future) lead clinical operations position. In addition, the job offers the great opportunity to play a major role within a huge and very important European project, ie, the Euro-Global Platform for Mechanism-Based Drug Repurposing, in which 3D-PharmXchange is participating (see for more info: https://repo4.eu/)
Your responsibilities include:
- On behalf of the client act as the primary counterpart for the clinical CRO and ensure an efficient working relationship with the CRO
- Take lead role/ project management role when applicable, eg. for the work package that 3D-PharmXchange is responsible for in the European Drug Repurposing project REPO4EU (https://repo4.eu/)
- Support in/ 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 meetings 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
- Extensive 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
- Be passionate to make a difference in the life of patients and their loved ones!
Interested?
Please attach your CV to our contact form!
Vacancy : Consultant Clinical Development - Clinical Science
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?
Please attach your CV to our contact form!
Vacancy : QA Specialist / Consultant - GMP/GDP
Company profile
3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and a side office in Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, chemistry, manufacturing and control (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
3D-PharmXchange is looking for a QA specialist/consultant – GMP/GDP, with experience in development and (preferably) commercialization processes of a myriad of products.
Our consultants work on projects for external clients and could include both small molecules as well as biomolecules (e.g. vaccines, cell-based therapies, monoclonals). As 3D-PharmXchange supports a wide range of projects throughout all phases of drug development, you will have the opportunity to grow substantially on your know-how.
As a QA specialist/consultant – GMP/GDP (Good Distribution Practice) you will be responsible for the GMP/GDP related activities at 3D-PharmXchange and it’s client projects within the product development phase. For client projects, you will be responsible for:
- Execution of external vendor audits and internal audits at our clients
- Preparation and review of Quality agreements
- Set-up and maintenance of Quality Management System (QMS)
- Participating in project teams, providing guidance regarding compliant development of a product
- Review and approval of GMP related documents that are generated during product development and clinical supplies, e.g. batch manufacturing records and validation documentation
- Review of batch release documentation
- Review of analytical data, methods and validations, risk assessments
- Perform QA review on regulatory documentation (IMPD’s, IND’s, NDA’s, etc.)
- Follow up on deviations, CAPAs and changes
- Be involved in due diligence projects
In addition, you will take the lead in 3D-PharmXchange related activities, including but not limited to:
- Execution of internal audits
- Maintenance the Quality Management System (QMS)
- Development/maintenance of GMP related procedures
- Training of colleagues
Requirements
- At least an academic level or bachelor’s degree in the area of life sciences or applied science
- Preferably at least >10 years of QA experience in a product development environment (pharma/biotech), covering all GMP aspects of QA
- Excellent knowledge of international guidelines on quality aspects of drug development
- Experience on commercial processes of a product is a pre
- Excellent knowledge of spoken and written English
- Autonomous as well as a team player
- Decisive and proactive
- Accurate and quality aware
Acquisition is not appreciated!
Interested?
Please attach your CV to our contact form!