Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

This position can be fully remotely based across Europe.

Discover Impactful Work:

We are currently looking for a highly skilled professional who possesses a track record in project management and a comprehensive understanding of all facets of clinical pharmacology. This individual will play a pivotal role in enhancing the design, execution, and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) data within clinical trials.

A day in the Life:

• Serve as Pharmacokinetic Project Lead on pharmacokinetic projects.

• Provide pharmacokinetic and clinical pharmacology input into the design of clinical study protocols.

• Plan, analyze, and interpret pharmacokinetic data from pharmacokinetic and clinical pharmacology studies.

• Provide pharmacokinetic reports and input into clinical study reports.

• Represent pharmacokinetic project team in cross-functional department activities and in client meetings.

• Manage pharmacokinetic project activities and timelines.

• Assist in clinical pharmacology initiatives.

• Assist in development and revision of department SOPs and guidelines for the conduct, analysis and reporting of clinical pharmacology and pharmacokinetic trials.

• Keep updates on the regulatory guidelines with respect to pharmacokinetics and related disciplines and current trends.

• Support lead pharmacokineticist on large or complex projects.

• Prepare pharmacokinetic reports and assist with the preparation of regulatory documents for submission.

Keys to Success:

Education & Experience

• Bachelor's degree (or equivalent) with previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or equivalent combination of education, training, and experience.

Knowledge, Skills, Abilities

• Proven management skills, as shown through management of multiple projects

• Good organizational skills with the ability to adapt and adjust to changing priorities

• Strong theoretical background in clinical pharmacology

• Ability to apply pharmacokinetic theory and concepts using relevant software such as Phoenix WinNonlin, NONMEM, SAS, S-Plus, R, or other pharmacokinetic packages

• Knowledge and experience in pharmacokinetics-pharmacodynamics modelling and simulation is preferred

• Good understanding of statistical methodology required in clinical research

• Familiarity with regulatory guidelines relevant to clinical pharmacology and pharmacokinetics areas of the drug development

• Excellent written and verbal communications skills

• Demonstrated initiative and motivation

• Positive attitude and the ability to work well with others

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.