Pharmacokineticist (remote or office-based)

Amazing opportunity to join our North America team in a home-based or office-based role! The Pharmacokineticist is responsible for the design, analysis and interpretation of pharmacokinetic, bioavailability, bioequivalence and pharmacodynamic clinical trials and assists with the preparation of final reports (provided to sponsors for submission to FDA). Clinical Pharmacology provides the clinical PK support necessary to elucidate the pharmacokinetics and PK/PD relationships in support of our client's new and generic drug development efforts. The Pharmacokineticist position is a "hands-on" position that provides both PK consultation and pharmacokinetic analyses. In addition to managing his or her own projects, the Pharmacokineticist will work with our pharmacokinetics team to assist our clients in the design, analysis, and interpretation of PK, PK/PD and population PK studies. The ideal candidates will have the experience, insight and skills necessary to provide interpretation of complex data and will be able to present this interpretation in a format and style that is compatible with client and FDA specifications. This position requires experience (at least academic experience) in pharmacokinetic analyses and modeling. The position requires one to identify priorities and shift resources to complete initial projects needing immediate attention. The individual must also be able to work effectively on several projects simultaneously. Clinical bioavailability studies must be organized so that they are conducted on schedule. Similarly, they must be conducted according to FDA guidelines to insure acceptance by FDA. Amazing opportunity to join our North America team in a home-based or office-based role! The Pharmacokineticist is responsible for the design, analysis and interpretation of pharmacokinetic, bioavailability, bioequivalence and pharmacodynamic clinical trials and assists with the preparation of final reports (provided to sponsors for submission to FDA). Clinical Pharmacology provides the clinical PK support necessary to elucidate the pharmacokinetics and PK/PD relationships in support of our client's new and generic drug development efforts. The Pharmacokineticist position is a "hands-on" position that provides both PK consultation and pharmacokinetic analyses. In addition to managing his or her own projects, the Pharmacokineticist will work with our pharmacokinetics team to assist our clients in the design, analysis, and interpretation of PK, PK/PD and population PK studies. The ideal candidates will have the experience, insight and skills necessary to provide interpretation of complex data and will be able to present this interpretation in a format and style that is compatible with client and FDA specifications. This position requires experience (at least academic experience) in pharmacokinetic analyses and modeling. The position requires one to identify priorities and shift resources to complete initial projects needing immediate attention. The individual must also be able to work effectively on several projects simultaneously. Clinical bioavailability studies must be organized so that they are conducted on schedule. Similarly, they must be conducted according to FDA guidelines to insure acceptance by FDA.

Education and Experience:

Ph.D. or PharmD., with an emphasis on clinical pharmacokinetics

0-3 years in the Pharmaceutical or CRO Industry

Must have experience with pharmacokinetic, medical, pharmaceutical and research concepts

Experience required in pharmacokinetic analysis and modeling; should have a proven record of accomplishments and publications

Knowledge of FDA pharmacokinetic /bioavailability/ bioequivalence criteriaStrong theoretical background in Pharmacokinetics and some experience in PK/PD modeling

Must be able to apply PK theory using SAS programming, WinNonlin, MATLAB, NONMEM or other pharmacokinetic packages

Knowledge, Skills and Abilities:

Excellent communication skills, both written and oral

Competent in pharmacokinetic theory and able to apply PK theory using SAS programming, PCNONLIN and other pharmacokinetic/statistical packages

Familiarity with pharmacokinetic modeling

Excellent organizational skills

Self-starter, able to initiate work and motivate others

Ability to keep others informed of progress

Excellent problem solving capabilities and organizational skills

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).

PPDHP

*LI-KF1

Education and Experience:

Ph.D. or PharmD., with an emphasis on clinical pharmacokinetics

0-3 years in the Pharmaceutical or CRO Industry

Must have experience with pharmacokinetic, medical, pharmaceutical and research concepts

Experience required in pharmacokinetic analysis and modeling; should have a proven record of accomplishments and publications

Knowledge of FDA pharmacokinetic /bioavailability/ bioequivalence criteriaStrong theoretical background in Pharmacokinetics and some experience in PK/PD modeling

Must be able to apply PK theory using SAS programming, WinNonlin, MATLAB, NONMEM or other pharmacokinetic packages

Knowledge, Skills and Abilities:

Excellent communication skills, both written and oral

Competent in pharmacokinetic theory and able to apply PK theory using SAS programming, PCNONLIN and other pharmacokinetic/statistical packages

Familiarity with pharmacokinetic modeling

Excellent organizational skills

Self-starter, able to initiate work and motivate others

Ability to keep others informed of progress

Excellent problem solving capabilities and organizational skills

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).

PPDHP

*LI-KF1