Description

Notes:

• Permanent Part-Time Role
• Local to Wilmington or Raleigh Durham, NC Area
• Onsite Preferred (but Hybrid Possible)

Summary:

Contribute to multi-disciplinary drug development and discovery efforts providing an integrated understanding of pharmacokinetics/pharmacodynamics (PK/PD), DMPK properties, and drug interaction (DDI) risk of novel therapies. Manages pharmacokinetic activities and timelines, analyzes and interprets pharmacokinetic data from clinical trials, and assists with other project related tasks identified. Ensures compliance of activities in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) set forth by PharPoint Research, Inc. and its sponsor clients.

Essential Duties and Responsibilities:

• Ability to contribute in a consultative manner on 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 as replated to PK/PD, DMPK, and DDI of novel therapies.
• Responsible for project oversight tasks related to PK deliverables, such as budgeting, business development and project tracking.
• Oversees the workflow and output quality, plans and reports of pharmacokinetic projects.
• Understand the contracted scope of work and plan monthly hours expected to complete each deliverable.
• Proficient in non-compartmental PK analysis and familiar with compartmental analysis techniques. Independently performs PK/PD modeling and simulation. Learns new PK methods as needed, and applies new skills to future projects.
• Perform queries and bring potential data problems to the team. Understand guidelines from the FDA, ICH, EMA, NIH, or other regulatory agencies as they apply to PK analysis for each project.
• Advise and write PK sections for clinical study reports, study synopses, and protocols.

• Prepare PK analysis plans.

• Document, analyze, create summaries, 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.

Position Requirements

Qualifications:

• Education: Bachelor’s degree (B.A./B.S.), Master’s degree, or Ph.D. in Pharmaceutical Sciences, Pharmacology, Biomedical Engineering, Biochemistry, or relevant fields.
• Experience: Bachelor’s degree with 10+ years relevant experience, Master’s degree with 8+ years relevant experience, or Ph.D. with 4+ years of industry experience in a relevant field.
• Certification/Licensure: None
• Other:
  • 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 demands 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. Be familiar with regulatory guidelines relevant to clinical pharmacology and pharmacokinetics areas of drug development. Experience in integrating preclinical DMPK and pharmacology to enable translational modeling and simulation to support dose selection, design of PK/PD and safety assessment studies, and dose justifications for clinical studies. Knowledge of the use of clinical PK for designing early-phase human studies.

Full-Time/Part-Time

Part-Time

EOE Statement

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.