Pharmacokinetic Specialist

About Syneos Health

Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model puts the customer and patient at the center of everything we do. We continuously simplify and streamline our work to make Syneos Health easier to work with and 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 to help our customers achieve their goals. We're agile and driven to accelerate the delivery of therapies because we're passionate about changing lives.

Why Syneos Health

• We're dedicated to developing our people through career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and total rewards programs.
• We're committed to our Total Self culture, where you can authentically be yourself. Our Total Self culture unites us globally, and we're dedicated to taking care of our people.
• We're continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.

Job Responsibilities

• Calculate pharmacokinetic parameters and perform statistical analysis using bioanalytical and clinical data, applying tested or validated software.
• Write the pharmacokinetic and statistical portions of reports for nonclinical studies and clinical studies by interpreting pharmacokinetic, pharmacodynamic, and statistical analysis results.
• Participate in intra and/or extra company scientific consultancy.
• Respond to deficiency letters from regulatory agencies on the conduct of pharmacokinetic and statistical analyses performed during clinical studies.
• Participate in the quotation process for functional area activities using internal databases, literature data, and pricing grids.
• Review study protocols in accordance with regulatory requirements using internal and/or literature data and design information appearing in in-house databases.
• Write/review standard operating procedures related to your work.
• Act as a consultant in clinical pharmacology study design development, such as optimal sampling, protocol review, etc.
• Perform comprehensive quality control/peer review procedures.
• Write data analysis plans in collaboration with statisticians and pharmacometricians.
• Participate in validation processes for electronic tools and procedures used during statistical analysis by carrying out tests and suggesting required specifications for end users.

Qualifications

What We're Looking For

• Bachelor's degree in Biopharmaceutical Sciences, Pharmacology, Experimental Medicine, or a related field.
• Extensive experience in clinical trials or an 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 technical topics and writing procedures or technical reports.
• Excellent communication, presentation, and interpersonal skills, with the ability to inform, influence, convince, and persuade.

Get to Know Syneos Health

Over the past 5 years, we've 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.