Pharmacokinetics Senior Specialist II

Thermo Fisher Scientific; United Kingdom; Remote; GBP 60,000 - 80,000; Full time

Job summary

A leading company in the biotechnology field is seeking a Pharmacokinetics Senior Specialist II for a remote role. This position involves conducting advanced modeling and simulation activities, supporting product development, and preparing regulatory submissions. The ideal candidate will hold a PhD with significant experience in pharmaceutical development, and will play an essential role in drug research and development initiatives.

Benefits

Competitive remuneration

Annual incentive plan bonus

Healthcare

Employee benefits

Career development opportunities

Qualifications

• Minimum 5-10 years of pharmaceutical development experience.
• In-depth knowledge of PK/PD modeling principles.
• Fluency in written and spoken English.

Responsibilities

• Conduct advanced PK/PD modeling and simulation research.
• Support product development and define drug effect relationships.
• Perform population PK/PD analyses for regulatory submissions.

Skills

Pharmaceutical development

Pharmacokinetics

Modeling and simulation

Systems biology

Data analysis

Communication

Education

PhD in Pharmaceutical Sciences, Clinical Pharmacology, or related field

Job description

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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

The position is responsible for the development and execution 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 PK-PD 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 mechanism-based modeling techniques, systems biology and disease progression models.
• Supports product development by defining dose-concentration-pharmacological effect relationships of a drug using modeling & simulation methodologies from data acquired at various development stages (Phase 1-3).
• 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 5-10 years of pharmaceutical development experience in the various aspects of modeling and simulation.
• In-depth knowledge of pre-clinical 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 cross-functional team environment (building strategic working relationships).
• Ability to multi-task 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, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Science

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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