Pharmacokinetics Senior Specialist II
Pharmacokinetics Senior Specialist II
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll 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 lifechanging 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.
The position is responsible for the development and of population pharmacokinetic PK and pharmacodynamic PD modeling and simulation activities related to the research design implementation data analysis interpretation reporting and publication of studies for products in any phase of development. Additional responsibilities include the generation and review of pharmacokinetics documents related to regulatory submissions preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies or Advisory Committee Meetings.
The position is responsible for supervising and conducting advanced population PKPD modeling and simulation exercises. Individual advancement is based in part on the degree of experience displaying a progression in the level of expertise and level of independence shown in contributing to drug development and the advancement of science both internally and externally. This is a remote based role.
Principal Responsibilities:
Within the area of modeling and simulation:
Under minimal supervision:
Conducts advanced pharmacokinetic (PK)/pharmacodynamic (PD) modeling and simulation research with emphasis on mechanismbased modeling techniques systems biology and disease progression models.
Supports product development by defining doseconcentrationpharmacological effect relationships of a drug using modeling & simulation methodologies from data acquired at various development stages (Phase 13.
Performs population PK/PD analyses in support of regulatory submissions.
Develops & reviews study designs writes analysis plans & reports analyses and interprets PK/PD data and results.
Maintains liaisons within and outside the organization. Represents the organization on scientific matters within the worldwide scientific community.
Identifies opportunities and ways to address drug development questions/issues.
Competencies and Experience:
PhD or equivalent in Pharmaceutical Sciences Clinical Pharmacology Chemical/Biomedical Engineering or Biological Sciences. With minimum 510 years of pharmaceutical development experience in the various aspects of modeling and simulation.
Indepth knowledge of preclinical and clinical pharmacokinetics and PK/PD modeling and simulation principles.
Fluent in written and spoken English
Good written and oral communication skills
Ability to build and maintain effective working relationships inside and outside the department; ability and willingness to work in a crossfunctional team environment (building strategic working relationships).
Ability to multitask and prioritize assignments establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning organizing and time management)
Ability to translate creative and innovative approaches into the solution of problems and the timely advancement of projects
Self motivated with the ability to work independently with minimal supervision (personal accountability)
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Required Experience:
Senior IC
Employment Type
Full-Time
