Associate Director - Global Study Lead
ROLE OVERVIEW
This Associate Director–Global Study Lead role places you at the center of GSK’s clinical development engine in Bengaluru, leading the operational planning and delivery of a global clinical study. The position is pivotal to GSK’s mission of uniting science, technology, and talent to get ahead of disease, supporting therapeutic areas such as respiratory, immunology, oncology, HIV, and infectious diseases. You will work across clinical operations, data management, safety, regulatory, and external partners, translating asset strategy into flawless study execution. With visible impact on pipeline milestones and patient outcomes, this is a compelling opportunity for seasoned clinical operations professionals seeking global matrix leadership, process innovation, and a direct role in advancing GSK’s ambitious health impact goals.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead end-to-end operational planning and delivery of assigned global clinical studies from feasibility through close-out.
- •Serve as Clinical Operations escalation point, resolving study-level issues and ensuring timely risk mitigation.
- •Ensure compliance with ICH-GCP, local regulations, and GSK SOPs across all study activities.
- •Translate asset and program requirements into study-level operational strategy and communicate with Clinical Operations Asset Lead.
- •Oversee protocol and informed consent form operational inputs, plus other key study documents.
- •Manage vendor assessment, selection, and performance for full-service outsourcing partners.
- •Drive inspection readiness and quality oversight, ensuring protocol compliance and audit preparedness.
- •Champion AI/ML tools and process automation to improve efficiency and study execution.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor’s or Master’s in life sciences, pharmacy, nursing, medicine, or related field; advanced degree preferred.
- 8–12 years of clinical research or clinical operations experience, including 3+ years leading global studies.
- Proven track record managing Phase I–III trials across multiple regions and therapeutic areas.
- Strong working knowledge of ICH-GCP, FDA/EMA/CDSCO regulations, and clinical trial lifecycle.
- Experience with full-service outsourcing vendor oversight and budget/contract management.
- Certification in project management (PMP) or clinical research (CCRA/ACRP) is advantageous.
- Demonstrated matrix leadership and decision-making in complex global environments.
PREFERRED QUALIFICATIONS
- •Therapeutic area experience in respiratory, immunology, oncology, HIV, or infectious diseases
- •Clinical data management and pharmacovigilance interface knowledge
- •Medidata, Veeva, or Argus safety systems familiarity
- •People management and matrix team leadership
- •Process improvement or automation certification
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
GSK (GlaxoSmithKline) is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. The company focuses on the research, development, and manufacture of innovative vaccines and specialty medicines. GSK's products address a wide range of diseases, aiming to impact the health of millions worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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