Pharmacokineticist

July 2 2024
Industries Pharmaceutical, Biotechnology
Categories Microbiology, Pharmacology, Pharmacokinetics, Pharmacovigilance,
Anywhere - Canada • Full time

Description

Pharmacokineticist

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities

  • Calculate pharmacokinetic parameters and perform statistical analysis using bioanalytical and clinical (or nonclinical) data, using tested or validated software.
  • Write the pharmacokinetic and statistical portions of reports for nonclinical studies (toxicokinetic) and clinical studies (early and late phases) by interpreting pharmacokinetic, pharmacodynamic and statistical analysis 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
  • Act as a consultant in clinical pharmacology study design development (e.g., optimal sampling, protocol review, etc.)
  • Perform comprehensive quality control/peer review procedures
  • Write data analysis plans in collaboration with the statisticians and pharmacometricians
  • Participate in validation processes for electronic tools and procedures used during statistical analysis, by carrying out tests and suggesting the required specifications for end users.

Qualifications

What we're looking for

  • B. Sc in Biopharmaceutical Sciences, Pharmacology, Experimental Medicine or in another related field.
  • Extensive experience in clinical trials or equivalent combination of education and experience with increasing levels of responsibility.
  • Extensive knowledge of the drug development process, regulatory requirements, and relevant guidelines.
  • Ability to apply knowledge of pharmacometrics design, analysis, and programming techniques used in clinical trials.
  • Required English language level includes communicating verbally and in writing on topics that are often technical and writing procedures or technical reports.
  • Excellent communication, presentation, and interpersonal skills, with an ability to inform, influence, convince, and persuade.

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.

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.

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