Associate Director EU CTR Strategy & Operations Excellence Lead

ppJob Scope: What is this job’s focus? /p pThe Associate Director, EU CTR Strategy Operations supports the Head of EU CTR in providing strategic, operational, and people leadership for the EU CTR Submission team. The role is accountable for the overall operational performance of the team, including line management of the EU CTR Submission organization, operational delivery, strategic planning, and continuous improvement of EU Clinical Trials Regulation (EU CTR) processes. /p pActing as the operational deputy to the Head of EU CTR, the Associate Director ensures high-quality, compliant, inspection-ready, and efficient execution of EU CTR submissions and lifecycle management activities while driving a harmonized and scalable operating model across all EU Member States. /p h3Strategic Leadership Operational Oversight /h3 ul liSupport the Head of EU CTR in defining and executing the EU CTR operational strategy and long-term operating model. /li liLead the operational execution of the EU CTR submission organization, ensuring delivery of compliant, high-quality, and timely CTIS submissions and lifecycle activities. /li liTranslate strategic objectives into operational priorities, resource plans, and organizational capabilities. /li liDrive organizational effectiveness and scalability to support future business growth. /li /ul h3Organizational Leadership Line Management /h3 ul liProvide direct line management for the EU CTR Submission team, including Senior Leads, Leads, and Specialists. /li lioversee a high- performing, engaged, and accountable submission team through coaching, mentoring, and performance management. /li liEstablish performance objectives, development plans, and succession strategies. /li liLead workforce planning, resource allocation, and capacity management. /li liFoster a culture of collaboration, accountability, continuous learning, and operational excellence. /li /ul h3Operational Excellence Governance /h3 ul liSponsor and oversee the EU CTR operating model, including governance frameworks, KPIs, operational controls, and performance dashboards. /li liEnsure alignment of EU CTR operational processes with corporate regulatory strategies and global process standards. /li liProvide executive oversight of process control reviews, quality metrics, inspection readiness, and operational risk management. /li liEnsure continuous improvement initiatives are implemented through the Lead, Strategy Operations Excellence. /li /ul h3Regulatory Compliance Inspection Readiness /h3 ul liEnsure compliance with EU CTR, CTIS requirements, EMA guidance, and internal quality standards. /li liProvide executive oversight for inspection readiness, internal audits, and regulatory inspections. /li liOversee CAPA implementation and operational risk mitigation. /li liAct as senior escalation point for complex regulatory and operational issues. /li /ul h3Capability Development Organizational Growth /h3 ul liDevelop organizational capability through leadership development, succession planning, and talent management. /li liSponsor the EU CTR learning strategy and capability framework. /li liMentor Senior Leads and Leads to build future leadership capability. /li liPromote a culture of continuous improvement and knowledge sharing. /li /ul h3Cross-functional Leadership /h3 ul liLead strategic collaboration with Regulatory Affairs, Clinical Development, Clinical Operations and Country and sites Operations /li liRepresent EU CTR Operations in senior governance forums. /li liBuild partnerships with regulatory authorities, CROs, and industry groups. /li /ul h3Essential Skills And Qualifications Required /h3 ul liAdvanced degree (Pharmacy, Life Sciences, or related discipline) or equivalent professional experience. /li liMinimum 12 years of experience in clinical or regulatory operations including within the EU region. /li liDemonstrated people leadership and talent development experience. /li liStrong background in process excellence, continuous improvement, and training program development. /li liDemonstrated leadership and influence in a complex, matrix environment. /li liStrong knowledge of the EU regulatory landscape, clinical trial operations, and regulatory submissions. /li liExcellent strategic thinking, problem-solving, and project management skills. /li liSuperior interpersonal, communication, and organizational abilities /li /ul h3Education /h3 pAdvanced degree (Pharmacy, Life Sciences, or related discipline) or equivalent professional experience. /p h3Experience /h3 pExtensive Minimum 12 years of experience in clinical or regulatory operations within the EU region, learning and capability building, process control and change management. /p pJob Level: Management /p h3Why Biogen? /h3 pWe are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. /p pAt Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen. /p pAll qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. /p /p #J-18808-Ljbffr