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Senior Clinical Pharmacology / Pharmacokinetic / Pharmacometric Consultant

We seek experienced senior-level drug development professionals for an exciting consulting opportunity to collaborate with our growing firm and expanding clientele that needs expertise in clinical pharmacology and PK.

Consultants will have the freedom to develop their own client base while contributing to projects provided by our consulting company. This unique opportunity provides individual senior consultants the stability of being associated with an established firm that can provide a base level of projects and scientific support staff while simultaneously maintaining their independence. We provide office space and business support to manage all business aspects of the work, including invoices, legal, marketing, business development, computers & IT support, SOPs, training, general & professional liability insurance, administrative efforts, etc.

The consultants will be experts in clinical pharmacology, PK, and PK/PD concepts as well as have knowledge of drug metabolism, physiology, and human and animal PK studies.

Responsibilities

  • Provide expertise for clients on current topics in PK and PK/PD science, regulatory strategy, FDA rulings, etc.
  • Direct and/or conduct non-compartmental and compartmental pharmacokinetic analysis
  • Conduct PK/PD analysis, population PK modeling and simulation
  • Function as the clinical pharmacology representative on client drug development team (i.e., integrated resource)
  • Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies
  • Provide strategic advice to clients, develop clinical pharmacology strategic plans, and take ownership/responsibility for client deliverables
  • Work with other consultants to prepare and review PK, PD, PD/PD, popPK reports and other clinical pharmacology documents
  • Perform nonclinical toxicokinetic analyses
  • Manage third-party vendors (bioanalytical labs and nonclinical lab)
  • Author clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc.
  • Represent clients at meetings with US and ex-US regulatory agencies
  • Support client’s nonclinical efforts to ensure that sufficient preclinical PK data exists to design and execute clinical studies

Qualifications

Individuals with advanced degree (MS, Ph.D., Pharm.D) and 15+ years of experience working with clinical pharmacology and pharmacokinetic strategies is highly preferred. The ideal individuals are currently or will soon be functioning as independent consultants and are looking to maintain that independence while taking advantage of the support that an established consulting firm can offer. Comfort working directly with C-level executives at biopharmaceutical companies is also important. Experience in working with small, emerging pharmaceutical and biotech companies and with small molecules and biologics is a plus. Willingness to support business development and marketing activities, foster client relationships, and bring new clients into the consulting firm is important.

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