SERM Scientific Director

SERM Scientific Director 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. The role supports one or more therapeutic areas, primarily Immunology. Provides in‑depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post‑marketing setting. Ensures scientifically sound review and interpretation of data, manages safety issues and escalates identified safety risks to senior management. Focuses on efficiency and effectiveness to meet the needs of patients and healthcare professionals, supporting pharmacovigilance and benefit‑risk management of the assigned portfolio of GSK global assets to ensure patient safety worldwide. Key Responsibilities Lead pharmacovigilance and risk‑management planning and develop strategies for evaluating issues in the clinical matrix. Lead the safety component of global regulatory submissions. Perform expert evaluation and analytical thinking for literature review, clinical data synthesis, analysis and interpretation. Provide quality decision‑making and creative problem resolution based on assessment of all relevant information and context. Demonstrate multi‑tasking skills, prioritise tasks and deliver consistently on deadlines with high quality standards. Explore positions and alternatives to reach mutually beneficial agreements and solutions. Lead safety governance by developing strategies and executing them for products in clinical and post‑marketing settings, anticipating and addressing product safety issues and ensuring risk‑reduction strategies are implemented. Facilitate safety governance in clinical and post‑marketing settings by establishing and operating cross‑functional teams to detect and address product safety issues, ensuring risk‑reduction strategies are implemented in clinical study protocols and/or product labelling. Represent GSK on cross‑functional Clinical Matrix Teams and/or Project Teams. Lead cross‑functional ad‑hoc teams to address urgent product safety issues. Lead or participate in cross‑functional process initiatives and/or Process Workstreams to improve adherence to regulations, data standards, quality and efficiency. Author or participate in written standard updates (e.g., SOPs) to ensure policies and regulations are adhered to correctly and consistently. Accountable for escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV). Build strong relationships and display excellent leadership skills on safety issues while working in a matrix team. Coach and mentor others. Lead presentations on recommendations or safety issues to senior staff members at GSK Senior Governance Committees. Interact with confidence, credibility and influence at all levels of the GSK organisation. Lead cross‑functional process improvement teams within GSK. Think strategically and tactically when considering safety issues and changes to SERM processes or business improvements. Contribute to development of long‑term strategy for clinical programs. Lead inspection readiness and prepare as needed to support audits and inspections. Communicate verbally and in writing and influence internally and externally. Basic Qualifications PhamD/PhD for Scientist (preferred) or Bachelor of Science in Life Sciences or Medical Sciences (minimum). Advanced experience (5+ years) in the pharmaceutical or biotech industry working in pharmacovigilance or drug safety. Significant pharmacovigilance experience in safety evaluation and risk management across clinical development and post‑marketing activities. Experience with signal detection and safety surveillance. Knowledge of international pharmacovigilance requirements (ICH, GVP modules, CIOMS initiatives) and drug development and approval processes. Experience working in large matrix organisations. Previous management experience (preferred for team lead role). Salary and Benefits US salary ranges for new hires in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: $169,950 – $283,250 per year. Position offers annual bonus and eligibility to participate in a share‑based long‑term incentive programme. Benefits include health care and insurance benefits for employee and family, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Legal Statements GSK is an Equal Opportunity Employer. This ensures that all qualified applicants 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, military service or any basis prohibited under federal, state or local law. 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. #J-18808-Ljbffr