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Vice President, Global Medical Safety (Copenhagen, Danish Capital Region, DK) @ H. Lundbeck A/S

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About this role

Vice President of Global Medical Safety Are you passionate about shaping how safety evidence informs the development, approval and safe use of innovative medicines throughout their lifecycle? Do you combine strong medical-scientific judgement with strategic leadership and the ability to lead through complexity and uncertainty? Would you like to shape the future of safety evidence generation and benefit-risk decision-making across an innovative neuroscience portfolio? If this sounds like you, here is an opportunity to lead Global Medical Safety and help safeguard patients while accelerating the development and responsible use of innovative therapies for brain diseases. Your new role As VP, Global Medical Safety, you will set the strategic direction for Global Medical Safety and lead a global organisation responsible for the medical-scientific assessment of safety throughout the lifecycle of Lundbeck's investigational and marketed products. You will have an opportunity to shape the future of medical safety at Lundbeck, advancing our approach from detecting and managing risks towards anticipating safety questions, proactively generating evidence and turning increasingly complex data into insights that guide benefit-risk decisions. You will have an important role in shaping how safety evidence informs development, regulatory and portfolio decisions, working closely with leaders and experts across R&D and the broader organisation. As VP, Global Medical Safety, you will: Set the strategic direction for Global Medical Safety , translating Lundbeck's R&D and Global Patient Safety priorities into a forward-looking medical safety strategy and building the capabilities required for an evolving portfolio. Advance proactive and integrated safety evidence generation , ensuring that emerging safety profiles, uncertainties and evidence gaps are identified early and addressed through scientifically robust strategies across development and the product lifecycle. Provide senior medical leadership and scientific oversight for benefit-risk decision-making, advising teams, senior management and governance bodies on complex safety questions, emerging risks and their implications for patients, clinical development and regulatory strategy. Embed safety into integrated evidence planning , partnering closely with Clinical Development, Biostatistics and Data Science, Regulatory Affairs, Medical Affairs, Epidemiology and other functions to generate the evidence needed for development, regulatory approval, labelling and responsible real-world use. Drive innovation in safety science , including the application of advanced analytics, quantitative methodologies, automation, AI and new data sources to enable more proactive, predictive and scalable safety surveillance and evidence generation. Ensure excellence across core medical safety accountabilities , including safety surveillance and signal management, aggregate safety assessment, risk management, benefit-risk evaluation, regulatory submissions and interactions, and medical support to the QPPV. Represent Global Medical Safety in key governance and decision-making forums , ensuring that safety considerations are translated into clear scientific and business-relevant recommendations. Provide senior safety leadership in interactions with health authorities and external experts , including regulatory meetings, advisory committees and other high-impact scientific discussions. Ensure inspection readiness and a strong quality and compliance mindset , while continuously evolving processes to make them scientifically robust, pragmatic and fit for purpose. Build and develop a high-performing global organisation , creating clarity of accountability, empowering scientific leaders and experts, developing future capabilities and fostering an environment characterised by trust, curiosity, collaboration and constructive challenge. Contribute beyond the boundaries of Global Medical Safety as a member of the Global Patient Safety Leadership Team and the broader R&D leadership community, bringing an enterprise perspective to strategic priorities, capability development and organisational transformation. Your future team Global Medical Safety is a global organisation of approximately 40 Safety Leads and Safety Scientists across Denmark, Singapore and the US. The organisation is responsible for safety evidence generation, safety surveillance, risk management and benefit-risk assessment across Lundbeck's portfolio, from early clinical development through the lifecycle of our marketed medicines. Global Medical Safety is part of Global Patient Safety, comprising approximately 100 colleagues committed to safeguarding patients and supporting the development and responsible use of innovative medicines in neuroscience. You will work in a highly cross-functional environment where safety science is increasingly integrated with clinical development, statistics and data science, regulatory strategy and evidence planning. What you bring to the team Our preferred candidate combines deep medical-scientific expertise with strategic leadership and a strong understanding of drug development. You have: A medical degree (MD or equivalent) Extensive experience from the pharmaceutical or biotechnology industry, with significant leadership experience within Patient Safety/Pharmacovigilance, Clinical Development or a closely related medical-scientific function. Deep understanding of clinical development and lifecycle safety, from first-in-human studies through registration and post-marketing use. Strong expertise in safety surveillance, safety evidence generation, signal evaluation, risk management and benefit-risk assessment. Demonstrated ability to exercise senior medical judgement in complex situations where evidence is incomplete, uncertainty is substantial and decisions may have significant implications for patients and development programmes . Experience contributing to major global regulatory submissions and interactions with health authorities, preferably across several major regulatory regions. A strong understanding of scientific methodology and an interest in evolving quantitative, data-driven approaches to safety assessment. Experience leading senior scientific professionals and building high-performing teams across functions and geographies. A successful track record of setting strategic direction and translating strategy into organisational priorities, capabilities and execution. Strong cross-functional and enterprise leadership, with the ability to connect scientific and regulatory considerations with development strategy and broader business objectives. Excellent influencing and communication skills, including the ability to simplify complex scientific issues and articulate clear recommendations to senior decision-makers. Experience with regulatory inspections, audits and complex safety or regulatory interactions. An innovative and digitally curious mindset, with an interest in how data science, automation and AI can strengthen safety science and transform ways of working. The courage and intellectual curiosity to challenge established approaches while remaining pragmatic about implementation. A leadership style that creates clarity and accountability while empowering highly qualified scientific professionals to exercise judgement and take ownership. Experience within neuroscience, rare diseases and/or development of innovative biological therapies would be an advantage. You are fluent in English, both written and spoken. Above all, you are motivated by the opportunity to use science, evidence and leadership to improve decisions for patients , and you enjoy working at the intersection of medical science, drug development, regulation and organisational leadership. Our promise to you This is a highly influential leadership position with the opportunity to shape both Global Medical Safety and the broader evolution of safety science at Lundbeck. You will join an international organisation with strong scientific expertise and work closely with senior leaders and experts across R&D. You will have the opportunity to influence development programmes across Lundbeck's portfolio, build new scientific and digital capabilities, and develop an organisation positioned for the future of patient safety. At Lundbeck, our purpose is focused on restoring brain health so every person can be their best. As a focused innovator in neuroscience, we offer an environment where scientific curiosity, collaboration and willingness to challenge established thinking can translate into meaningful impact for patients. Annual base salary range: 1 351 000 - 1 857 900 DKK gross At Lundbeck, we are committed to fair and transparent pay. Please note that the final base salary within the stated range will be based on relevant qualifications, skills, competencies, and level of proficiency as well as internal pay equity. Apply now Can you see yourself in this role? If so, we want to hear from you. Upload your CV and include a few lines about your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience. Applications must be received by 27-SEP-2026. We do encourage you to apply at your earliest convenience as review of applications will commence prior to the application deadline. Learn more about us at www.lundbeck.com , LinkedIn or Instagram (@h_lundbeck). #EveryBrainInTheGame This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

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