Preclinical PKPD Scientist (Client - dedicated), EMEA

Join Us as Principal Pharmacokineticist - Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in clinical pharmacology. You will guide design of nonclinical studies (PK, TK, PKPD), translational PKPD analysis in collaboration with the clinical Pharmacologist, support the bioanalytical scientist in strategic and operational planning of nonclinical and early clinical work.

What You'll Do:

• Is responsible for managing and safeguard nonclinical PKPD data

• Interacts and discusses data and strategies with stakeholders and vendors for PKPD analysis

• Advises and sets up adequate software infrastructure in collaboration with IT

• Discusses development strategies with technical and cross-functional teams and advises on design of nonclinical studies including GLP toxicology studies

• Reviews study reports including Toxicokinetic phase reports

• Processes and models data using appropriate software (such as Phoenix WinNonlin, R)

• Reports results to nonclinical pharmacology and bioanalytical team, cross-functional teams and management

• Prepares documents to a quality standard required for Regulatory/Health Authority submissions

• Interacts with internal stakeholders to understand different project requirements and ensures timely, open and effective communication to relevant stakeholders (teams, collaborators, management)

• Applies model informed drug development (MIDD)

Do you have experience in Communication skills?, Do you have a Master's degree?, Advanced degree (Master or PhD) in a scientific discipline with a strong mathematical component or equal by experience

• PKPD modelling experience in translational and early phases of development. Experience in different disease areas is a plus

Knowledge, Skills and Abilities: * Basic understanding of GLP requirements for nonclinical safety studies

• Knowledge of regulatory requirements to characterize the nonclinical pharmakinetics and safety of new biologic entities and how to propose and justify human starting doses
• Strong communication skills
• Strong collaborative and interpersonal skills
• Problem solving skills
• Fluent in English

We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. With $1.4 billion invested annually in R&D, our collaborative and diverse teams have the resources they need to drive new discoveries and do cutting-edge research and develop important applications and tools that help millions of lives around the world.
Thermo Fisher Scientific Inc. is the world leader in serving science, with an annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000+ colleagues deliver an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.