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GlaxoSmithKline - GSK is one of the world's leading science and research-based pharmaceutical and healthcare companies. The company possesses a share of approxi
Medical Director
Location
North Carolina + 2 moreAll locations: North Carolina | Pennsylvania | United Kingdom
Posted
75 days ago
Salary
0
Seniority
Lead
Job Description
Medical Director
GlaxoSmithKline - GSK
Title: SERM Medical Director Location: London, United Kingdom; Durham, North Carolina; Collegeville, Pennsylvania Medical and Clinical 434564 Job Description: Site Name: GSK HQ, Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: Apr 2 2026 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 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 safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks. Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally. Key Responsibilities Scientific/Medical Knowledge PV Expertise - Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix. - Leads the safety component of global regulatory submissions. - Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation. - Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context. - Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality. - Explores positions and alternatives to reach mutually beneficial agreements and solutions. Cross-functional Matrix team leadership - Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately. - Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling. - Represents GS 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 drive efforts to improve adherence to regulations, data standards, quality and efficiency. - Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently. - Accountable for the 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 whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting. Ability to coach and mentor others. Communications (verbal, written) and Influencing (internal PV Governance and External LTs) - Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees. Has the skillset to interact with confidence, credibility, and influence at all levels of the GSK organisation. In addition, is expected to represent GSK and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners. - Leads cross-functional process improvement team within GSK. Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements. Contributes to development of long-term strategy for clinical programs. Regularly contributes innovative ideas to address new issues or improve approaches to existing operations. - Leads inspection readiness and prepared as needed to support audits/inspections. - Excellent communication (verbal, written) and influencing (internally and externally) skills. Why You? Basic Qualification We are looking for professionals with these required skills to achieve our goals: - Medical degree - Completion of a formal postgraduate clinical training, clinical residency or specialty training - Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety - Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities - Experience with Signal Detection and safety surveillance - Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes. - Experience working in large matrix organizations Preferred Qualification If you have the following characteristics, it would be a plus: - Experience leading cross-functional safety governance or Senior Review Teams. - Immunology SERM background - Experience with safety databases, safety systems configuration or validated computerized systems. - Project or change management experience within regulated environments. - Experience engaging with regulatory authorities or external safety working groups. - Track record mentoring or managing scientific colleagues in safety roles. - Previous Management experience (if offered management role) - Completion of advanced specialty training, fellowship or country-equivalent higher-level qualification in Immunology, leading to recognition as a medical specialist through formal certification, board certification or country-specific professional designation What you will gain You will expand your influence across global safety operations and develop skills in safety strategy, regulatory interactions and cross-functional leadership. The role gives you the chance to shape processes that protect patients and to grow your career within a global organisation committed to scientific rigour and collaboration. 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 focus time and effective 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. We encourage candidates from many backgrounds to apply. 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. 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.
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Postdoctoral Medical Fellow - Applied Biostatistics, Clinical Trial Simulation
BoehringerPRDTo learn more about why BI is a great place to work, visit: Boehringer Ingelheim Careers .
Role Description The gBDS / Med Data/AI, Boehringer Ingelheim is seeking a Postdoctoral Research Fellow to help advance the development of robust clinical trial simulation tools aimed at improving the probability of success for clinical trials by integrating multimodal datasets. This is an applied research and implementation role—focused on evaluating rigorous statistical methodology from the research stage into confirmatory, pivotal clinical studies. It is an exceptional opportunity for candidates looking to bridge academia and industry from a clinical statistical research perspective, working at the intersection of methodological rigor and real-world drug development impact. The fellow will focus on identifying, integrating, and applying fit-for-purpose methods and data to inform trial design and execution decisions—supporting faster, more reliable studies through improved feasibility assessment, operational risk forecasting, and robust inference under real-world trial constraints. 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