SERM Scientific Director
At GSK, we aim to positively impact the health of 2.5 billion people by the end of the decade through vaccines and medicines.
This position supports one or more of the following therapeutic areas: Respiratory, Infectious Diseases/HIV, Hepatitis/Fibrosis, Neurology/Dementias.
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 and management of safety issues, and escalates issues to senior management and safety governance when appropriate. Makes recommendations for further characterization, management, and communication of safety risks.
Focuses on efficiency and effectiveness to meet the needs of patients and healthcare professionals. Supports pharmacovigilance and benefit‑risk management of the assigned portfolio of GSK global assets to ensure patient safety worldwide.
Key Responsibilities
* Leads pharmacovigilance and risk management planning and develops strategy for evaluation of issues in the clinical matrix.
* Leads the safety component of global regulatory submissions.
* Performs expert evaluation and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
* Demonstrates quality decision making and creative problem resolution based on assessment of all relevant supporting and conflicting information and the wider context.
* Demonstrates highly developed multitasking skills, prioritizes tasks and consistently delivers on deadlines with high performance standards for quality.
* Explores positions and alternatives to reach mutually beneficial agreements and solutions.
* Leads safety governance by developing safety strategy and its execution for products in clinical development and post‑marketing settings, anticipating, detecting and addressing product safety issues and ensuring risk‑reduction strategies are implemented appropriately.
* Facilitates safety governance/SRTs in clinical development and post‑marketing settings by establishing and operating cross‑functional teams in any SERM to detect and address product safety issues, ensuring risk‑reduction strategies are implemented in clinical study protocols and/or product labeling.
* Represents GSK on cross‑functional clinical matrix teams and/or project teams; leads cross‑functional ad hoc teams to address urgent and important product safety issues.
* Leads or participates in cross‑functional process initiatives and/or process workstreams to improve adherence to regulations, data standards, quality and efficiency.
* Authors or participates 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).
* Builds strong working relationships and displays excellent leadership skills on safety issues while working in a matrix team, and demonstrates ability to coach and mentor others.
* Leads presentations on recommendations or safety issues to senior staff at GSK Senior Governance Committees, and represents GSK at meetings with regulatory authorities, external consultants and partners.
* Leads cross‑functional process improvement teams within GSK, contributes to long‑term strategy for clinical programs, and brings innovative ideas to address new issues or improve existing operations.
* Leads inspection readiness and prepares for audits/inspections.
Basic Qualifications
* PharmD/PhD in Science (preferred), or Bachelors of Science in Life Sciences or Medical Sciences (minimum).
* Advanced experience in the pharmaceutical or biotech industry working in pharmacovigilance or drug safety.
* Significant pharmacovigilance experience related to safety evaluation and risk management, encompassing both clinical development and post‑marketing activities.
* Experience with signal detection and safety surveillance.
* Knowledge of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS) and drug development and approval processes.
* Experience working in large matrix organizations.
Why GSK?
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together.
GSK is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, 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.
#J-18808-Ljbffr