Description

Senior Pharmacokineticist

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
We are continuously building the company we all want to work for and our customers want to work with. Why Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Act as a scientific and technical resource person within Syneos Health for the pharmacokinetics and pharmacodynamics fields and perform complex pharmacokinetic and/or pharmacodynamic analyses.
Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or nonclinical) data using tested or validated software
Write the pharmacokinetic and statistical sections of clinical (early and late phases) or nonclinical (toxicokinetic studies) reports including interpretation of the results
Participate in intra and/or extra company scientific consultancy
Answer to deficiency letters from regulatory agencies on the conduct of the pharmacokinetic and statistical analyses performed during clinical studies
Participate to the quotation process for the functional area activities using internal database, literature data and pricing grid
Review study protocol in accordance with regulatory requirements using internal and/or literature data, and design information appearing in inhouse database.
Write/review standard operating procedures related to his/her work
Use quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development and decision making under the supervision of pharmacometricians
Participate in the development of structured and standardized data modeling practices and related SOPs
Act as a consultant in clinical pharmacology study design development (e.g., optimal sampling, protocol review, etc.)
Perform comprehensive quality control/peer review procedures
Act as a scientific and technical resource person within Syneos Health for the pharmacokinetics and pharmacodynamics fields and perform complex pharmacokinetic and/or pharmacodynamic analyses.
Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or nonclinical) data using tested or validated software
Write the pharmacokinetic and statistical sections of clinical (early and late phases) or nonclinical (toxicokinetic studies) reports including interpretation of the results
Participate in intra and/or extra company scientific consultancy
Answer to deficiency letters from regulatory agencies on the conduct of the pharmacokinetic and statistical analyses performed during clinical studies
Participate to the quotation process for the functional area activities using internal database, literature data and pricing grid
Review study protocol in accordance with regulatory requirements using internal and/or literature data, and design information appearing in inhouse database.
Write/review standard operating procedures related to his/her work
Use quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development and decision making under the supervision of pharmacometricians
Participate in the development of structured and standardized data modeling practices and related SOPs
Act as a consultant in clinical pharmacology study design development (e.g., optimal sampling, protocol review, etc.)
Perform comprehensive quality control/peer review procedures

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

The Senior Pharmacokineticist acts as a scientific and technical resource person within Syneos Health for the pharmacokinetics and pharmacodynamics fields and performs complex pharmacokinetic and/or pharmacodynamic analyses.