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.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and implement high-quality, cost-efficient clinical studies.

The Pharmacokineticist is responsible for the design, analysis and interpretation of pharmacokinetic, bioavailability, bioequivalence and pharmacodynamic clinical trials and assists with the preparation of final reports.

Clinical Pharmacology provides the clinical PK support necessary to elucidate the pharmacokinetics and PK/PD relationships in support of our client's new and generic drug development efforts. The Pharmacokineticist position is a "hands-on" position that provides both PK consultation and pharmacokinetic analyses. In addition to handling their own projects, the Pharmacokineticist will work with our pharmacokinetics team to assist our clients in the design, analysis, and interpretation of PK, PK/PD and population PK studies. The ideal candidates will have the experience, insight and skills necessary to provide interpretation of complex data and will be able to present this interpretation in a format and style that is compatible with client and FDA specifications.

Collaborate closely with feasibility managers and strategists, project management, clinical management and biostatistics for the coordination of high-quality feasibility assessments. Independently coordinate feasibility projects and deliverables according to contractual obligations. Actively participate in process development and change initiatives within the group, which may include the development and delivery of training on departmental requirements and other areas that impact feasibility conduct.

• Ph.D. or PharmD., with an emphasis on clinical pharmacokinetics

• 0-3 years in the Pharmaceutical or CRO Industry
• Experience with pharmacokinetic, medical, pharmaceutical and research concepts
• Experience required in pharmacokinetic analysis and modeling; should have a consistent record of accomplishments and publications
• Strong theoretical background in Pharmacokinetics and some experience in PK/PD modeling
• Able to apply PK theory using SAS programming, WinNonlin, MATLAB, NONMEM or other pharmacokinetic packages

• Excellent communication skills, both written and oral
• Competent in pharmacokinetic theory and able to apply PK theory using SAS programming, PCNONLIN and other pharmacokinetic/statistical packages
• Familiarity with pharmacokinetic modeling
• Excellent organizational skills
• Self-starter, able to initiate work and motivate others
• Ability to keep others advised of progress
• Excellent decision-making capabilities and organizational skills

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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.

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.

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