Senior Director, Safety Pharmacology
Glaxosmithkline
Business Introduction 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. Find out more: Our approach to R&D Senior Director, Safety Pharmacology Safety Pharmacology sits at the interface of discovery, non‑clinical development, regulatory strategy and patient safety. As Senior Director, you'll provide scientific vision and operational leadership for GSK's global Safety Pharmacology group within Non‑Clinical Safety (NCS) - shaping strategy from early discovery through regulatory submission, and building the team and science that get us there. You'll lead delivery of core battery and follow‑up safety pharmacology studies across species, modalities and routes of administration, partnering with CROs and internal stakeholders to solve safety problems and de‑risk development decisions. This is a role for a scientific leader who wants to set direction, not just execute it - someone who can operate as the single point of accountability for safety pharmacology across a global project portfolio while developing the next generation of scientists in the discipline. We're also looking for someone to lead the discipline through its next transformation: applying AI and machine learning to predictive toxicology, in silico safety assessment and New Approach Methodologies, and building the practices and governance needed to use these tools with regulatory confidence. Key Responsibilities Provide scientific, strategic and operational leadership for the global Safety Pharmacology function, acting as the single point of accountability for safety pharmacology deliverables to project teams worldwide. Design, implement and execute safety pharmacology strategy - core battery and bespoke studies investigating human‑relevant target organ risk - spanning cardiovascular, respiratory and CNS assessment, and integrating findings with screening and drug disposition data to advise on hazard/risk assessment and mitigation. Act as senior scientific advisor to discovery and development project teams, leadership and governance committees across multiple therapeutic areas. Oversee the design, interpretation and regulatory reporting of non‑clinical safety pharmacology studies, ensuring data and reports meet GLP requirements and hold up to internal, external and regulatory scrutiny. Drive translational safety science, predictive toxicology and New Approach Methodologies (NAMs) including AI/ML‑based predictive models to sharpen decision‑making, reduce development risk and reduce reliance on traditional in vivo testing. Champion the adoption of AI and machine learning across the Safety Pharmacology function: identifying where predictive and generative models can accelerate study design, data interpretation and risk assessment. Optimize cycle times across internal and CRO‑run studies, and build the processes, including AI/data‑driven tools, to monitor and continuously improve delivery efficiency. Partner closely with Toxicology, DMPK, Clinical Safety, Regulatory Affairs, Research, and Data Science/AI teams to embed safety pharmacology thinking, and capability, early and throughout the pipeline. Represent GSK externally with regulators, at scientific conferences, and through industry consortia and academic collaborations - building the company's profile and influence in specialised safety testing. Build, mentor and develop talent across the Safety Pharmacology team, including upskilling scientists, and maintain a motivated, innovative and high‑performing team. As a member of the Non‑Clinical Safety Leadership Team, contribute to resolving cross‑functional scientific and operational issues and to shaping NCS strategy. Ensure compliance with GSK values, SOPs, GLP, data integrity, safety and animal welfare guidelines. Required Qualifications & Experience BSc in Life Sciences, Biomedical Sciences, Pharmacology or a related discipline, with 10+ years of relevant industry experience in non‑clinical drug development, including significant leadership experience in Safety Pharmacology. Deep understanding of cardiovascular, respiratory and CNS safety assessment, and strong knowledge of ICH S7A/S7B guidance and global regulatory expectations. Experience leading a group responsible for safety pharmacology project support, including regulated and non‑regulated studies delivered internally and via CRO partners. Extensive knowledge of pharmacology, toxicology and/or related biological sciences, with demonstrated ability to apply this to drug discovery and development. Strong track record advising on safety pharmacology strategy, designing in vitro and in vivo investigative and regulatory studies, and contextualising results for both non‑clinical and clinical audiences. Demonstrated track record supporting regulatory submissions and progressing candidates from discovery into clinical development. Experience leading multidisciplinary teams in a global, matrixed organisation, with a track record of developing and motivating people. Hands‑on experience driving the adoption of AI/ML‑enabled approaches in safety pharmacology or predictive toxicology, with working knowledge of model validation and data quality. A strong external scientific profile and established key opinion leadership in the field. Preferred Qualifications PhD in Pharmacology, Toxicology or a related biological science, gained in a drug discovery and development environment. Strong leadership skills with demonstrated vision, strategic thinking and experience leading through change. Comfort working across organisational boundaries, building cross‑functional matrix collaborations and teams. Experience managing budgets and resources. Skilled at coaching, mentoring, developing and performance managing staff.
#GSK-LI
Skills Animal Models, Design of Experiments (DOE), Drug Discovery Process, Molecular Modelling, Pharmaceutical Regulatory Compliance, Pharmacology, Regulatory Documents, Regulatory Submissions, Toxicology Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at View email address on click.appcast.io GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at #J-18808-Ljbffr GlaxoSmithKline- GSK in Collegeville, PA is seeking a Senior Director for Safety Pharmacology to provide scientific vision and leadership across global programs. You will shape strategy, oversee core battery and specialty studies, and collaborate with CROs and internal teams to de-risk...Senior
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