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Research Director Pharmacokinetics

5-7 years
Not Disclosed
10 July 8, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Research Director – Pharmacokinetics

Location: Bengaluru, India
Job Type: Full-Time
Work Mode: On-site (Office-based)


Job Summary:

IQVIA is hiring a Research Director – Pharmacokinetics to lead the planning, analysis, and regulatory submission of clinical pharmacology and PK/PD studies across Phases I–IV. This leadership role requires deep expertise in pharmacokinetics, population modeling, regulatory documentation, and client consultation. You will oversee protocol development, regulatory strategy, and technical delivery to support innovative drug development programs globally.


Key Responsibilities:

  • Lead protocol design, statistical analysis planning, and clinical reporting for pharmacokinetic and pharmacodynamic (PK/PD) studies.

  • Manage studies including dose tolerance, mass balance, QTc, DDI, and special population assessments.

  • Consult clients and internal teams on PK/PD study design and clinical development plans.

  • Prepare global regulatory documents, including dossier submissions and agency communications.

  • Ensure timely and high-quality PK/PD deliverables, coordinating with cross-functional project teams.

  • Mentor and train junior staff; lead scientific reviews and QC processes.

  • Support proposal and budget development for new Clinical Pharmacology projects.

  • Maintain awareness of industry trends, scientific advancements, and global regulatory requirements.


Required Skills & Qualifications:

  • Ph.D., Pharm.D., or Master’s in Pharmacokinetics, Pharmaceutics, or a related field (mandatory).

  • Minimum 5–7 years of relevant experience in PK/PD and clinical pharmacology.

  • Strong expertise in non-compartmental analysis, population modeling, and PK software.

  • Proficiency with WinNonlin, NONMEM, S-Plus, SAS, and SigmaPlot.

  • Deep knowledge of ICH-GCP, FDA/EMA regulations, and clinical development processes.

  • Excellent analytical, communication, mentoring, and client-interaction skills.

  • Ability to manage multiple complex projects and lead cross-functional global teams.


Perks & Benefits:

  • Opportunity to lead global clinical pharmacology programs.

  • Work with cutting-edge pharmacokinetic modeling tools and technologies.

  • Competitive compensation and professional development programs.

  • Collaborative, cross-disciplinary team environment.


About the Company:

IQVIA is a global leader in healthcare intelligence, clinical research, and data analytics. With a commitment to transforming patient care and accelerating innovation, IQVIA delivers integrated solutions to leading pharma and biotech companies worldwide.


Work Mode:

On-site – Bengaluru, India


Call-to-Action:

Are you an expert in PK/PD ready to lead global pharmacokinetics strategy? Apply now to shape the future of clinical pharmacology at IQVIA.