Clinical Pharmacologist

Gleneagles BGS Hospital Kengeri

Bengaluru

On-site

INR 120,000 - 240,000

Full time

6 days ago
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Job summary

Gleneagles BGS Hospital Kengeri seeks a pharmacology-focused professional to design clinical trial protocols and oversee PK/PD analyses. The role involves collaboration with statisticians, toxicologists, and clinical teams to drive drug development milestones.

The candidate should have experience with regulatory submissions and safety profiling, along with strong pharmacovigilance capabilities in a hospital or pharmaceutical setting.

Qualifications

  • Experience designing clinical trial protocols and endpoints.
  • Proficiency in PK/PD modeling and data interpretation.
  • Familiarity with regulatory submissions and safety profiles.

Responsibilities

  • Clinical Trial Design: Develop study protocols, endpoints, and dosing strategies for Phase III trials.
  • PK/PD Analysis: Evaluate ADME data using modeling and simulation software.
  • Regulatory Compliance: Prepare safety profiles and data packages for submissions to regulatory agencies.
  • Cross-Functional Collaboration: Work with statisticians, toxicologists, and clinical teams to interpret results.
  • Pharmacovigilance: Monitor adverse drug reactions and provide prescribing recommendations to clinicians.

Skills

Clinical trial design
PK/PD analysis
Regulatory compliance
Pharmacovigilance
Cross-functional collaboration

Tools

Modeling software

Job description

Role & responsibilities
  • Clinical Trial Design: Develop study protocols, select proper dosing strategies, and define endpoints for Phase IIII clinical trials.
  • PK/PD Analysis: Evaluate absorption, distribution, metabolism, and excretion (ADME) data using modeling and simulation software.
  • Regulatory Compliance: Prepare safety profiles and data packages to support submissions to regulatory agencies like the US FDA or EMA.
  • Cross-Functional Collaboration: Work with bio-statisticians, toxicologists, and clinical teams to interpret results and guide drug development milestones.
  • Pharmacovigilance: Monitor adverse drug reactions and provide prescribing recommendations to medical professionals
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