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| Global Head of Clinical Operations |
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Roche Professional Diagnostics (RPD) seeks a Global Head of Clinical Operations to work within the Medical Affairs group in the division's Global Headquarters in Rotkreuz, Switzerland. This role embodies strong leadership and works proactively with RPD colleagues to identify and meet critical data needs for clinical development and regulatory approval of new and existing products. This person is responsible and accountable for ensuring delivery of high quality work products that meet customer (internal and external) needs on time and on budget. Key responsibilities include (but are not limited to):
Acts as primary spokesperson for the International Clinical Operations function (under guidance of Head of Medical Affairs).
Directs the functional organization of all clinical operations activities (including diagnostic performance evaluations, registration and pre/post-registration clinical trials) for the product Lifecycle teams. Ensures harmonisation of processes and consolidation of resources across the different RPD Clinical Operations sites (Indianapolis, Penzberg, Mannheim, and Rotkreuz)
Through direct reports, develops and leads the implementation of the overall clinical development and validation strategy in alignment with the broader business strategies. Oversees the planning and execution of clinical studies that provide data for PMA, 510k registration and CE-mark for US, EMEA, and Japanese regulatory authorities (studies to support primary clinical claims as well as claim expansions).
Oversees execution of post-marketing clinical trials of CE-marked and FDA-registered products as directed by the Clinical Development Teams.
Oversees execution of highly complex, outcomes-based clinical utility and health economic studies insuring clinical accuracy and medical relevance.
Develops core competencies and sourcing strategies for functional areas needed for the execution of studies, such as monitoring, data management, medical writing, etc.
Supervises sample procurement activities to obtain samples for studies and banking of specimens.
Develops and drives international interfaces that will incorporate efficient use of global resources with linkages to global clinical strategy and prioritization resulting in high quality clinical trial performance and accelerated regulatory clearances/approvals.
Oversees and owns Clinical Operations processes related to clinical studies according to SOPs/LOPs. |
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Doctorate
Postdoctorate
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15 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Zug |
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Post-doctoral degree (MS, MPH, PhD or PharmD) preferred
Must have 10+ years experience in clinical trials with 7+ years of management and leadership experience in clinical operations within the pharmaceutical or biotech industry and/or experience in a Clinical Research Organization.
Experience in managing CRO relationships preferred
Mastery of applicable standards and regulations for clinical trials and laboratory conduct (CFR, ICH, Federal guidelines, GMP, GLP, ISO)
Experience in regulatory strategy for FDA approval of in-vitro diagnostics strongly preferred.
Should have experience managing multimillion-dollar international budgets.
Competency to design and implement cross-functional processes required.
Must demonstrate ability to build and foster multidisciplinary global relationships.
Fluent in English, cultural sensitivity and flexibility.
Position will be based in Switzerland. Must be willing and able to travel approximately 50% of time. |
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At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.
The headquarters in Basel is one of Roche’s largest sites. It is home to the Corporate Executive Committee, the Pharmaceuticals and Diagnostics Divisions and the global business functions. Roche Basel also covers the entire business chain from research, development and production through to marketing. Over 8,000 people from more than 60 countries work at the site. |
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