Your new role
The (Senior) Scientist Clinical Pharmacology and Quantitative Science will provide pharmacology expertise to programs through all stages of research and development, with a focus on early stage assets. The key responsibility for this position is to contribute to dose decision making towards first in human (FIH) trials and recommended Phase 2 dose (RP2D). Therefore, the role requires extensive collaboration with early-stage development teams, translational research, and non-clinical safety, conducting quantitative PK/PD/safety/efficacy analyses for integration into overall program strategies.
The successful candidate will help generate in-depth understanding of all aspects of PK and PD of your employer’s next generation antibody technologies by building and refining platform quantitative system pharmacology models and applying these models to guide rational experimental designs and critical decisions on candidate antibody therapies. The candidate will also contribute to the design of non-clinical studies and will be responsible for interpretation and reporting of PK, TK and PD of drug candidates. This is an exciting opportunity to be part of a passionate, high profile, high-impact Clinical Pharmacology and Quantitative Science team, and to work in a highly dynamic and collaborative setting, with opportunities for professional development.
• Provides pharmacology support to multi-disciplinary study teams for pre-clinical programs.
• Helps define and execute PK/PD modeling and simulation plans to guide rational first in human dose projection and dose selection.
• Contributes expert pharmacology input into key pre-clinical and regulatory documents including study protocols, study reports, investigator brochures, and other documents within agreed timelines.
• Contributes to building and refining platform quantitative system pharmacology models to generate in-depth understanding of PK/PD characteristics of proprietary antibody technologies.
• Assumes responsibility for TK, PK and PD evaluation and reporting in assigned non-clinical studies.
• Leads pharmacology efforts (e.g., study design, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions.
• Analyzes results, interprets, and recommends action based on study results.
• Performs PK and PK/PD analyses using a variety of tools and approaches.
• Integrates, interprets, and reports data to project teams and other customers.
• Serves on Global Pre-Clinical Development Teams and provides a source of Pharmacology expertise and advice to other functions across the company.
• A PharmD or PhD in Clinical Pharmacology, Pharmacology, Pharmacokinetics, or related discipline is required. • Approximately 0-5 years of experience in pre-clinical and/or clinical pharmacology in pharma, biotechnology, or consulting.
• Experience with analysis of pre-clinical and/or clinical PK/PD data, allometric scaling, noncompartmental PK analysis is also required • Affinity for quantitative methods and demonstrated ability to apply modeling and simulation approaches to pre-clinical and clinical drug development are required.
• Hands-on experience with programming in R is highly desired.
• Experience with application of quantitative tools such as WinNonLin/Phoenix, NONMEM, and/or other PK/PD analysis software is preferred.
• An understanding of antibody therapeutics development and experience in the field of oncology or immunology are considered beneficial.
• Flexible, with a positive and proactive attitude, ability to work with multidisciplinary teams, prioritize projects effectively and communicate at all levels within the company.
• Excellent written, verbal, and interpersonal communication skills.
About the organization
You will work for an international biotech company specializing in the creation and development of innovative differentiated antibody therapeutics for the treatment of cancer and the improvement of the lives of cancer patients. The company has been active for almost 25 years and they now have over 1000 people working for them. Their headquarters are in Denmark and next to this office, they have sites in the US, Japan and the one in Utrecht that you might join!
Your new employer offers you a suitable salary that fits your experience and expertise. Of course, you will also get good secondary benefits such as a 1 year contract with the intention to convert to a permanent contract afterwards. They also offer an annual bonus, holiday pay (8%), stocks, a good pension scheme (2/3 paid by employer), 25 holidays, travel expenses and a hybrid working policy. You will be working in an informal, multicultural environment where inclusiveness, openness and support are key words.
What you need to do now
Are you interested in this vacancy as (Senior) Scientist, Clinical Pharmacology & Quantitative Science? Click 'Apply' and send an up-to-date CV or call Merel Hasselo on +31620076590. If this vacancy is not exactly what you are looking for, but you are looking for a different position, please contact us for a confidential discussion about your career options. #1045494
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between 70K-100K gross yearly depending on experience
Spreek met een consultant
Spreek met Merel Hasselo, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam