Manager, Pharmacokinetics
ProClinical AG
Manager, Pharmacokinetics - Perm - Durham, NC
Proclinical is seeking a Clinical Pharmacokineticist to join a multi-disciplinary team at a CRO.
Primary Responsibilities:
The successful candidate will play a crucial role in our drug development and discovery efforts, providing an integrated understanding of pharmacokinetics/pharmacodynamics (PK/PD), DMPK properties, and drug interaction (DDI) risk of novel therapies. This role involves managing pharmacokinetic activities and timelines, analyzing and interpreting pharmacokinetic data from clinical trials, and assisting with other project-related tasks.
Skills & Requirements:
- Bachelor's degree (B.A./B.S.), Master's degree, or Ph.D. in Pharmaceutical Sciences, Pharmacology, Biomedical Engineering, Biochemistry, or relevant fields.
- Strong written and oral communication skills.
- Proficiency with MS Office applications including Word, Excel and PowerPoint.
- Ability to multi-task and meet changing deadlines and work independently, as needed.
- Experience in assessing impact of various factors on the PK/PD of novel therapeutics and communicating analyses and recommendations to teams.
- Familiarity with regulatory guidelines relevant to clinical pharmacology and pharmacokinetics areas of drug development.
The Manager, Pharmacokinetics's responsibilities will be:
- Contribute to any phase of a clinical trial project, from initial meeting with an investigator to final review of a manuscript prior to submission for publication or to the FDA.
- Oversee project tasks related to PK deliverables, such as budgeting, business development, and project tracking.
- Plan and report on pharmacokinetic projects, ensuring workflow and output quality.
- Perform non-compartmental PK analysis and familiarize with compartmental analysis techniques.
- Independently perform PK/PD modeling and simulation.
- Advise and write PK sections for clinical study reports, study synopses, and protocols.
- Prepare PK analysis plans and present results in written and verbal form to team and sponsors.
- Ensure adherence to all departmental systems and SOPs.
- Organize and work simultaneously on multiple projects.
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsenat Write an email
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
ProClinical AG
Durham
