Site Name: USA - Pennsylvania - Upper Providence Posted Date: Dec 18 2024 We are seeking a highly motivated Scientific Leader with expertise in Hepatitis B Virus (HBV) to join the Infectious Disease Research group in Upper Providence, Pennsylvania. In this role, you will be responsible for writing and reviewing non-clinical virology regulatory documents and conducting non-clinical laboratory studies supporting a late-stage asset. The ideal candidate will have extensive experience in non-clinical virology and regulatory report writing, a strong background in HBV, and the ability to independently manage complex projects. Key Responsibilities: Regulatory Document Preparation Author, review, and finalize high-quality non-clinical virology regulatory documents including but not limited to Non-clinical Study Reports, Investigator Brochures, Briefing Documents, and sections of regulatory submissions (e.g., NDAs, MAAs). Laboratory Studies: Conduct laboratory studies to support the non-clinical development of an HBV asset. Design and execute experiments, analyze data, and interpret results to inform regulatory submissions. Expertise in HBV: Provide HBV virology subject matter expertise to ensure scientific accuracy and compliance with regulatory requirements. Project Management: Ensure timely delivery of high-quality documents and study results. Manage multiple projects simultaneously, prioritize tasks, and coordinate with internal and external stakeholders. Compliance and Standards: Ensure regulatory documents and laboratory studies comply with GSK standards, regulatory guidelines, and industry best practices. Collaboration: Collaborate with cross-functional teams (e.g, Regulatory Affairs, Clinical Biomarkers, Matrix Partners) to execute project strategies that support the overall project goals and timelines. Mentorship and Training: Provide guidance and mentorship to junior scientists in the laboratory to ensure successful delivery of non-clinical virology data packages. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MS plus 7+ years pharmaceutical experience or PhD plus 3+ years pharmaceutical experience, with a significant focus in virology. Previous experience in authoring non-clinical virology study reports for regulatory submissions. Preferred Qualifications: If you have the following characteristics, it would be a plus: Demonstrated leadership skills with the ability to manage stakeholders across functional areas. Ability to work effectively in cross-functional teams and build strong professional relationships. Ability to adapt to changing priorities and work in a fast-paced environment. Significant prior research experience and expertise in HBV biology. Proficient in non-clinical virology laboratory techniques. Proactive and highly self-motivated self-starter with strong strategic thinking skills. Excellent written and verbal communication skills, with the ability to convey complex scientific information clearly and concisely. Strong attention to detail, commitment to quality and excellent time management skills. Strong publication record in peer-reviewed scientific journals and active participation in scientific conferences and forums. Familiarity with clinical biomarker analyses, regulatory requirements, and drug development processes. 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 special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. 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