Director Global Oncology Medical Affairs Clinical Operations (m/f/d)

Daiichi Sankyo Europe GmbH; München; On-site; EUR 120,000 - 180,000; Full time

Job summary

Bei Daiichi Sankyo Europe GmbH suchen wir eine/n Director, Company Sponsored Studies (CSS) in Global Oncology Medical Affairs. Sie leiten globale interventionalische und nicht-interventional Studien und Forschungsprojekte im Bereich Onkologie, gewährleisten GCP-Konformität, Budgeteinhaltung und termingerechte Lieferung in einer matrixorganisierten, internationalen Umgebung.

Sie tragen die strategische und operative Führung über den Studienlebenszyklus, arbeiten eng mit Medical Affairs, Clinical

Qualifications

• Master's degree in Life Sciences is required; PhD or PharmD preferred.
• Minimum of 8 years strong GxP related, international clinical operations experience in a global pharmaceutical company, and/or Contract Research Organization (CRO), preferrably within Oncology environment
• Proven experience leading global interventional and non-interventional clinical studies and working within Medical Affairs units
• Excellent knowledge of GCP, global clinical trial regulations, vendor oversight, and study management
• Self-responsibility with excellent project leadership, stakeholder management, and communication skills
• Ability to thrive in a global, cross-functional matrix organization
• Professional English, written and spoken

Responsibilities

• Lead the operational planning, execution, and delivery of global oncology company-sponsored interventional and non-interventional studies and medical affairs research projects, ensuring compliance with GCP, regulatory requirements, DS policies, timelines, budgets, and quality standards
• Serve as Global Study Lead, driving cross-functional, global study teams and coordinating all relevant activities across Medical Affairs, Clinical Operations, Regulatory Affairs, Safety, Data Management, Stats., Quality, etc. as well as with external partners
• Oversee and direct CROs and external vendors from selection through study completion, ensuring effective and compliant performance management, risk mitigation, budget oversight, and high quality delivery of milestones and study objectives
• Provide strategic and operational leadership throughout the study lifecycle, including study planning, protocol development support, study start-up, execution, and final study reporting
• Represent the GOMA Company Sponsored Studies (CSS) group on global asset, program and study teams, acting as the primary point of contact for GOMA clinical operational activities and collaborating closely with internal functional teams, alliance partners and regional stakeholders
• Drive continuous improvement of clinical operations processes, systems, SOPs, and quality standards to enhance GOMA study execution and operational excellence across GOMA
• Identify, assess, and proactively manage study and program risks, ensuring appropriate mitigation strategies and effective escalation of critical issues

Skills

GxP experience

Global study leadership

Stakeholder management

Clinical operations

Education

Master's degree in Life Sciences

PhD or PharmD preferred

Job description

Bei Daiichi Sankyo stehen wir vereint hinter einem einzigen Ziel: Das Leben auf der ganzen Welt durch innovative Medikamente zu verbessern. Mit aktiver Innovation seit 1899, Präsenz in mehr als 30 Ländern und über 19.000 Mitarbeitern entwickeln wir bahnbrechende Therapien in der Onkologie, für Herz-Kreislauf-Erkrankungen, seltene Krankheiten und Immunerkrankungen. Im Einklang mit unserer Vision 2030, "ein innovatives globales Gesundheitsunternehmen zu sein, das zur nachhaltigen Entwicklung der Gesellschaft beiträgt", gestalten wir eine gesündere, hoffnungsvollere Zukunft für Patienten, ihre Familien und die Gesellschaft.

About The Role

As Director, Company Sponsored Studies (CSS) within Global Oncology Medical Affairs (GOMA), you will lead the operational strategy and execution of global company-sponsored interventional and non-interventional studies and medical affairs research projects in oncology. Acting as Study Lead, you will drive study delivery from planning through close-out, ensuring compliance, quality, timelines, and budget adherence while working in a highly collaborative, cross-functional, global matrix environment. The position can be filled at one of our European affiliates (including Canada; with a preference for placement in Germany) or the US.

Key Responsibilities

• Lead the operational planning, execution, and delivery of global oncology company-sponsored interventional and non-interventional studies and medical affairs research projects, ensuring compliance with GCP, regulatory requirements, DS policies, timelines, budgets, and quality standards
• Serve as Global Study Lead, driving cross-functional, global study teams and coordinating all relevant activities across Medical Affairs, Clinical Operations, Regulatory Affairs, Safety, Data Management, Stats., Quality, etc. as well as with external partners
• Oversee and direct CROs and external vendors from selection through study completion, ensuring effective and compliant performance management, risk mitigation, budget oversight, and high quality delivery of milestones and study objectives
• Provide strategic and operational leadership throughout the study lifecycle, including study planning, protocol development support, study start-up, execution, and final study reporting
• Represent the GOMA Company Sponsored Studies (CSS) group on global asset, program and study teams, acting as the primary point of contact for GOMA clinical operational activities and collaborating closely with internal functional teams, alliance partners and regional stakeholders
• Drive continuous improvement of clinical operations processes, systems, SOPs, and quality standards to enhance GOMA study execution and operational excellence across GOMA
• Identify, assess, and proactively manage study and program risks, ensuring appropriate mitigation strategies and effective escalation of critical issues

Qualifications

• Master's degree in Life Sciences is required; PhD or PharmD preferred
• Minimum of 8 years strong GxP related, international clinical operations experience in a global pharmaceutical company, and/or Contract Research Organization (CRO), preferrably within Oncology environment
• Proven experience leading global interventional and non-interventional clinical studies and working within Medical Affairs units
• Excellent knowledge of GCP, global clinical trial regulations, vendor oversight, and study management
• Self-responsibility with excellent project leadership, stakeholder management, and communication skills
• Ability to thrive in a global, cross-functional matrix organization
• Professional English, written and spoken

Warum Sie bei uns richtig sind

Bei Daiichi Sankyo zu arbeiten, ist mehr als nur ein Job – es ist Ihre Chance, das Leben von Patient*innen zu verbessern. Dieses ehrgeizige Ziel können wir nur gemeinsam erreichen. Deshalb pflegen wir eine Kultur des gegenseitigen Respekts und des kontinuierlichen Lernens, die von Vielfalt und Inklusion geprägt ist. Hier haben Sie die Möglichkeit, sich weiterzuentwickeln, mutig zu denken und Ihre Ideen einzubringen. Sie arbeiten proaktiv und möchten sich für die Bedürfnisse von Patient*innen einsetzen? Dann bewerben Sie sich jetzt!