Redbock - an NES Fircroft company · 2 hours ago

Pharmacology

United States

Contract

Remote

Senior Level, Lead/Staff

10+ years exp

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BiotechnologyConsulting

Growth Opportunities

Hiring Manager

Thomas Wilson

Insider Connection @Redbock - an NES Fircroft company

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Responsibilities

Lead the design of clinical pharmacology studies (bioavailability, bioequivalence, pharmacokinetics, and pharmacodynamics), ensuring regulatory compliance and alignment with scientific goals.

Work with cross-functional teams to develop clinical trial protocols, providing pharmacological expertise throughout trial planning and execution.

Analyze and interpret pharmacokinetic (PK), pharmacodynamic (PD), and exposure-response data, offering recommendations to internal teams and senior management.

Oversee the use of pharmacometrics, managing internal and external resources to meet modeling and simulation needs.

Ensure all activities adhere to FDA, EMA, and other relevant regulatory guidelines.

Contribute to scientific publications, regulatory submissions, and presentations related to clinical pharmacology findings.

Participate in quality initiatives and collaborate with the quality group to develop SOPs.

Qualification

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PharmDPopulation PharmacokineticsModelingSimulationClinical Pharmacology Study DesignGxP RegulationsGlobal Regulatory GuidelinesPharmacometric Management

Required

PharmD or PhD in Pharmaceutics, Pharmacology, Biology, or a related field with 10+ years of biotech/pharma experience

Strong experience in Population Pharmacokinetics (popPK) and Modeling and Simulation (M&S) approaches

Experience in clinical pharmacology study design, including DDI, organ impairment, TQT, BE/rBA, and special populations, particularly in targeted immunology therapeutics

Strong understanding of GxP regulations and familiarity with global regulatory guidelines

Experience managing pharmacometrics or clinical pharmacology study vendors

Excellent critical thinking skills, with the ability to proactively identify and address potential issues