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Pharmacokinetics Senior Specialist II

Job Id R-01310009 Job Type Full time Category Clinical Research Remote Fully Remote

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO). 
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

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!

Accessibility/Disability Access
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
 
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EEO & Affirmative Action Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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