Clinical Microbiologist, Associate Director

Overview

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

We’re uniting science, technology, and talent to get ahead of disease together. Our approach to R&D can be found here.

We are seeking a deep expert microbiologist to lead aspects of late‑stage development of candidate anti‑infective medicines. In this role you will contribute to overall development strategy as well as design and oversee microbiological studies and interpret results to inform further development and regulatory submissions. You will lead others through matrix working relationships, mentorship, or direct reporting structure. You will collaborate closely with clinical teams, pharmacology, CMC, and regulatory colleagues to build data packages, troubleshoot unexpected findings, and answer questions during regulatory and standards agency reviews.

• Provide strategic oversight, lead the design, oversee execution, and interpret results of microbiology studies to advance clinical development of anti‑infective medicines.
• Drive collaboration with cross‑functional teams to develop and execute project strategies that support the overall project goals and timelines.
• Manage multiple projects simultaneously, prioritize tasks, and coordinate with internal and external stakeholders to ensure timely delivery of high‑quality documents and data packages.
• Draw from established experience in Pharma industry to proactively foster innovation and resolve complex scientific and technical challenges.
• Provide guidance and mentorship to junior scientists to ensure successful delivery of microbiology data packages. May be accountable for the growth, development and oversight of direct reports.
• Lead communication of study results and scientific findings through written reports, presentations, and publications.
• Author high quality Regulatory Study Reports and manuscripts in peer‑reviewed journals; contribute to IP patent filing and regulatory document preparation.
• Ensure compliance with regulatory requirements, ethical guidelines, and GSK standards for data integrity, safety, and quality.

• BS with 15+ years’ relevant experience or MS with 10+ years’ relevant experience or a PhD with 4‑6 years’ relevant experience with the degree in Microbiology or another relevant major.
• Hands‑on experience with bacteriology laboratory techniques and knowledge of microbiology regulatory (e.g. FDA, EMA) and/or standards organization (e.g. CLSI, EUCAST) guidance/guidelines.
• Substantial, hands‑on experience in delivering comprehensive microbiology data packages to regulatory agencies and supporting the review process, with a track record of successful submissions and regulatory approvals.
• Experience translating complex microbiological data into actionable guidance for late‑stage development decisions.
• Experience with clinical trial design and quality systems (GLP/GCP), ensuring compliance and excellence in execution.

• Proven ability to lead and manage research studies with external partners, driving significant scientific advancements and fostering impactful collaborations.
• Exceptional problem‑solving skills, with a track record of seamlessly advancing experiments from concept to high‑quality, actionable data.
• History of delivering high‑quality outcomes within tight timelines, while exercising sound judgment to balance risk and maintain scientific rigor.
• Authorship of peer‑reviewed publications, technical reports, and regulatory documents that demonstrate thought leadership.
• Proficiency in leveraging statistical methodologies and bioinformatics tools to distill complex datasets into clear, meaningful insights.
• Pro…