Career

For the development of the various projects we run for our clients, we are currently looking for:

Career

3D-PharmXchange is interested in high-level experts in all key drug development disciplines. Candidates should 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.

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 you will have freedom to shape your work.

3D-PharmXchange does not accept unsolicited resumes from any third-party recruiters or agencies. Acquisition is also not appreciated

Consultant Clinical Development

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.
As a consultant, you will be responsible for the development of clinical strategy and clinical operations of (bio)pharmaceutical compounds. You will be involved in drafting clinical development plans of clinical trials and documentation for regulatory submission.
You are
• Responsible for the clinical development strategy of an investigational compound, including the definition of milestones and Go/NoGo criteria
• Being able to translate biomarker data to decisive proof-of-concept studies
• Responsible for the design, execution and reporting of clinical trials according to timelines and within budget
• Responsible for the writing of essential documents e.g. Clinical Trial Protocol, IB etc.
• A clinical representative in Scientific Advice meetings at regulatory authorities (EMA, FDA)
• A clinical representative in a cross functional collaborative environment.
• An equal and expert discussion partner in the communication with KOL’s
• Managing external partners/service providers
• Guiding operational clinical activities
• Coordinating of project management activities to ensure timely, uniform and quality delivery of the services provided to our clients

REQUIREMENTS
• 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;
• Evidence of good scientific and clinical judgment, flexibility, and resilience
• Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines;
• Experience with Scientific Advice meetings at EMA or FDA is a pre.
• Well-developed organizational talent
• Strong sense of meeting milestones, timelines & budgets
• Excellent communication and presentation skills
• Excellent writing skills (English)
• 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
• Strong interpersonal and communication skills to drive results in a cross functional collaborative environment.

Interested? Send your CV and short motivation letter to 3D-PharmXchange at info@3d-pxc.com. For more information, you can contact Nina van Erp on +31 (0)13 5348272.
Acquisition is not appreciated

(Senior) Consultant CMC - Biologicals

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, medical devices 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. 3D-PharmXchange employees are able to look beyond borders and have an ambition to grow in a young, expanding and dynamic organization. To strengthen our team, we are looking for an experienced (Senior) Consultant CMC – Biologicals.

JOB DESCRIPTION
We are looking for a (senior) consultant Chemistry Manufacturing and Control (CMC) - Biologicals. As a (senior) consultant, you will work on customer projects related to development of biopharmaceutical compounds. Our clients usually request a strategic person with hands-on experience. Depending on the project, you will be responsible for managing the entire CMC development, where your experience in process development, manufacturing, and analytics help you lead teams and challenge other team members. Project Management is one of your core competences. You have a solid scientific background and will be involved in writing development protocols, reports, and documents for regulatory purposes.
Our customers will generally outsource elements of development, manufacturing, and analytics of drug substance and drug product to external parties. Therefore, selection of CMOs and CROs, tech transfer and management of CMOs/CROs will be part of your responsibilities.

REQUIREMENTS
• MSc (or, preferably, PhD) in the area of (Analytical) Chemistry, Pharmaceutical Sciences, or Bio(process)technology
• 10+ years of experience in early to late stage Biologics development
• Experience in managing outsourced activities
• Experience in (regulatory) requirements related to different phases of product development
• Experience in the service industry is preferred
• Experience in Drug Product formulation is preferred
• Essential communication skills: fluency in English, oral, written and presentation skills
• Extensive experience in writing development reports, protocols, and documents for regulatory purposes.
• Strong project management skills
• 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 3D-PharmXchange at info@3d-pxc.com. For more information, you can contact Nina van Erp on +31 (0)13 5348272.
Acquisition is not appreciated