3D-PharmXchange is a drug development consultancy company located in Tilburg, Oss and Amsterdam. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and long-lasting relationships. Our team of experts covers the key areas in drug development of non-clinical, clinical, CMC, QA and regulatory affairs. In addition, we provide project leadership and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups and academia.
For the various projects that we are running for our clients, we are seeking a (senior) consultant Clinical Development & Clinical Pharmacology, who can provide scientific direction and strategic input across clinical programs and studies for investigational (bio)pharmaceutical compounds. The role involves integrating clinical science, clinical pharmacology, and cross-functional evidence generation to support efficient, high-quality clinical development.
- Contribute to clinical development strategies, including scenario planning, evidence-generation strategies, defining milestones, key decision criteria.
- Support to translate nonclinical, biomarker and translational insights into proof-of-concept and early development strategies.
- Contribute to the development of clinical study designs, including patient population, dose-selection rationale, and innovative/adaptive elements.
- Contribute to endpoint strategy, including endpoint selection, development, validation, and assessment plans.
- Support design of early-phase clinical pharmacology studies (SAD/MAD, DDI, BA/BE, PK/PD).
- Draft or support development of key documents (e.g. clinical protocols, Investigator’s Brochures, clinical pharmacology plans, and regulatory briefing materials, SAP-aligned content).
- Contribute to dose-selection strategies, including PK/PD interpretation, exposure-response assessment, and dose justification for all development phases.
- Interpret study data (efficacy, safety, biomarkers, PK/PD) and contribute to scientific reports, presentations, and client recommendations.
- Represent the clinical and pharmacology perspective in meetings with health authorities together with senior colleagues or independently depending on experience.
- Act as clinical/pharmacology representative in a cross-functional collaborative environment, working closely with regulatory, statistics, safety, translational science, operations, etc.
- Participate in scientific discussions with Key Opinion Leaders (KOLs) and external experts.
- Contribute to internal knowledge development and best practices in clinical development and clinical pharmacology.
- Academic background in a relevant biomedical field; preferably PhD.
- A minimum of 5+ years of experience in clinical pharmacology and/or (early) clinical drug development
- Experience with development of clinical strategies, innovative study designs, and clinical development plans.
- Understanding of endpoint development and validation, study design principles and PK/PD concepts.
- Familiarity with ICH-GCP and regulatory expectations.
- Experience with health authority interactions (EMA, FDA) is a plus.
- Strong analytical and excellent scientific writing skills in English.
- Ability to manage multiple projects and adapt to evolving client needs.
- Proactive, collaborative, and client-focused mindset.
- Be part of a dynamic group of more than 35 experienced drug development experts
- Enjoy a company culture that prioritizes work/life balance
- Flexible remote working options
- We offer strong development pathways and the opportunity to grow into senior roles
- Competitive salary along with a bonus plan, excellent secondary benefits, including pension
- Work alongside a team of friendly and supportive colleagues
If you are a proactive professional who loves variety and enjoys working in a non-standard, high-energy setting, apply today!
Send your CV and short motivation letter to Laura van der Hulst, at [email protected].
Acquisition is not appreciated!
