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Gsk logo

SERM Scientific Director

Gsk
Posted 5 days ago
🇬🇧United Kingdom🏢Hybrid📁Healthcare/Clinical
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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 Position Summary Provides medical and scientific leadership in the safety evaluation and risk management of ViiV assets in clinical development. Responsible for the interpretation of safety data, identification and escalation of safety signals, and delivery of clear, evidence-based recommendations to support benefit–risk decisions. This role contributes to global governance and plays a critical part in protecting patient safety and shaping the safety profile of innovative specialty medicines. Key Responsibilities Scientific / Medical & Pharmacovigilance Expertise Lead pharmacovigilance and risk management activities for assigned ViiV assets and clinical trials Define and drive strategy for the evaluation and management of safety issues across the clinical development lifecycle Analyse and interpret clinical data, literature, and emerging evidence to identify and assess safety signals Provide expert medical input into the safety components of global regulatory submissions Apply sound clinical judgement to complex and sometimes conflicting data sets to inform benefit–risk decisions Ensure timely escalation of safety concerns in line with governance processes Matrix Leadership & Cross-functional Collaboration Represent Safety on cross-functional Clinical Matrix and Project Teams Lead cross-functional teams to address urgent and complex product safety issues Actively contribute to and, where appropriate, lead Safety Review Teams (SRTs) Build strong, collaborative relationships across functions and geographies Coach and mentor colleagues, contributing to capability development within the organisation Ensure effective communication and alignment with Safety Leads, senior SERM leadership, and key stakeholders Communication, Influence & Governance Lead presentations on safety issues and recommendations to senior governance committees Influence decision-making through clear, credible, and evidence-based communication Represent GSK in interactions with regulatory authorities, external experts, and partners Contribute to the development of safety strategy for clinical programmes and broader SERM activities Identify opportunities to improve processes, drive innovation, and enhance operational effectiveness Operate with strong awareness of the internal and external regulatory and scientific environment Why Join Us? This is an opportunity to play a pivotal role in advancing GSK’s Specialty pipeline, with direct impact on patient safety and global health outcomes. You will: Shape the safety strategy of innovative specialty medicines Engage with senior governance and influence key development decisions Work within a highly collaborative, global matrix environment Contribute to scientific excellence and continuous improvement in safety science Basic Qualifications Medical degree (for Medical Director) or Bachelors Degree (for Scientific Director) Completion of formal postgraduate clinical training (e.g., residency or specialty training) for Medical Director Significant experience in pharmacovigilance, drug safety, or medical affairs Demonstrated expertise in signal detection, evaluation, and risk management Experience of asset clinical safety development and post-marketing safety Experience working effectively in matrixed, cross-functional environments Excellent written and verbal communication skills, including preparation of medical and regulatory documents Strong clinical judgement and the ability to deliver clear, evidence-based recommendations Preferred Qualifications Postgraduate specialisation in a clinical discipline or pharmaceutical medicine PhD or PharmD (for Scientific Director) Experience contributing to regulatory submissions and periodic safety reports Knowledge of epidemiology, biostatistics, or real-world evidence relevant to safety assessment Experience leading Safety Review Teams or acting as safety lead for major programmes Prior engagement with regulatory authorities and external safety forums Demonstrated ability to coach and develop colleagues in medical, scientific, or safety roles Working Model This role is hybrid, based in the United Kingdom. You will be expected on site for key meetings, governance activities and team collaboration. Remote working is supported to balance focused work and stakeholder engagement. How to apply If this role speaks to you, please apply with your CV and a short note describing a safety assessment or risk management activity you led and its impact. If you need reasonable adjustments to apply or interview, tell us and we will support you. We welcome candidates from many backgrounds and encourage you to apply. Skills Digital Fluency, Enterprise Leadership, Influencing Without Authority, Pharmacovigilance, Presentation Techniques 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. GSK is an Equal Opportunity Employer. This ensures that 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 (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [email protected] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. 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 https://openpaymentsdata.cms.gov/

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