Pharmacokineticist- United States or Canada! Job at PPD
JOB DESCRIPTION
PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
We are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight.
As a Pharmacokineticist, you will design pharmacokinetic, bioavailability, bioequivalence and pharmacodynamic clinical trials through analysis and interpretation of pharmacokinetic and pharmacodynamic results.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose:
Designs pharmacokinetic, bioavailability, bioequivalence and pharmacodynamic clinical trials through analysis and interpretation of pharmacokinetic and pharmacodynamic results. May act as lead pharmacokineticist on projects and participate on large projects with complexity.
Essential Functions:
Serves as Lead Pharmacokineticist or Pharmacokinetic Project Lead on pharmacokinetic projects.
Provides pharmacokinetic and clinical pharmacology input into the design of clinical study protocols.
Plans, analyzes, and interprets pharmacokinetic data from pharmacokinetic and clinical pharmacology studies.
Provides pharmacokinetic reports and input into clinical study reports
Represents pharmacokinetic project team in cross-functional department activities and in client meetings.
Manages pharmacokinetic project activities and timelines.
Assists in clinical pharmacology initiatives.
Assists in development and revision of department SOPs and guidelines for the conduct, analysis and reporting of clinical pharmacology and pharmacokinetic trials.
Keeps updates on the regulatory guidelines with respect to pharmacokinetics and related disciplines and current trends.
Supports lead pharmacokineticist on large or complex projects.
Prepare pharmacokinetic reports and assists with the preparation of regulatory documents for submission.
Job Qualification
Education and Experience:
Masters's degree or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent combination of education, training, and experience
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job.
Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills and Abilities:
Strong theoretical background in pharmacokinetics
Ability to apply pharmacokinetic theory and concepts using relevant software such as WinNonlin, NONMEM, SAS, S-Plus, R, or other pharmacokinetic packages
Knowledge and experience in pharmacokinetics-pharmacodynamics modeling and simulation is preferred
Good understanding of statistical methodology required in clinical research
Familiarity with regulatory guidelines relevant to clinical pharmacology and pharmacokinetics areas of the drug development
Proven management skills, as shown through management of multiple projects
Good organizational skills with the ability to adapt and adjust to changing priorities
Excellent written and verbal communications skills
Demonstrated initiative and motivation
Positive attitude and the ability to work well with others
Work Environment:
PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.
PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more details).
PPD Defining Principals:
We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD.
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you!
Diversity Statement
COVID-19 Vaccination Update for U.S. Colleagues
- All U.S. colleagues are required to report vaccination status. New hires will be asked to report vaccination status within the first two weeks of employment.
- All U.S. new hires who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), remote site monitors-local (RSM-L) all CRA and RSM-L line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment.
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