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Head of Development Operations (f/m) Munich Germany,  


Posted on : 01 May 2017

Project Description

Head of Development Operations (Sr Mgr Development Operations) (m/f)Responsibilities:The Head of Development Operations is the primary Global Study Operations (GSO) contact at the country level, leads & delivers clinical research at the country level in accordance with GCP and local regulations, oversees the quality and scientific integrity of clinical operations, and provides leadership into overall GSO activities:Develops the local strategy to ensure delivery of Global Development Operations (GDO) goals in the countryDrives the implementation of global strategic decisions at local levelResponsible for efficient operation of local GSO activities  including budget, staffing and vendor managementEnsures quality and operational excellence in compliance with Good Clinical Practice (GCP), Amgen standards and local regulationsEnsures alignment with local functions, countries and regional GSORepresents GSO at the local and global level, including global leadership of initiatives/projectsEnsures appropriate Amgen GSO representation at external facing engagementsKey activities:Accountable for feasibility assessments and study commitments and deliverablesOversees country progress to study goals and ensure effective action plans to deliver quality and productivity deliverablesManages escalated study issues, where appropriate with local Medical Director (MD), Regional Head, Clinical Program Operations Manager and/or other cross-functional partnersInspection readiness activitiesLocal resource planning, operating expense and budget managementStaff recruitment, coaching, development, talent management and succession planningStructures interactions with internal business partners and local Functional Services Provider(s) (FSPs)Represents Amgen at external stakeholder meetingsDrives country strategic R&D plan jointly with local MD(s)Participates in global projects as Global Study Operations representativeDevelops local process The Head of Development Operations reports to the German Executive Medical Director with a dotted-line to the Director & Regional Head Clinical Site Management.Qualifications:M.D./B.Sc. (Life Sciences); Masters degree/Ph.D. preferredMinimum 7 years in pharmaceutical/biotech industryClinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO companyClinical operations experience in Germany and/or regional study management experienceExperience at, or oversight of, outside clinical research vendors (CROs, central labs, imaging vendors, etc.)Leadership/management experience of direct reports, ideally including management level staffInternational collaborationKnowledge Detailed knowledge of local country and international clinical trial management including regulations and guidelines Knowledge in Amgen s main therapeutic areasClinical trial processes and operationsClinical project and programme managementGCP & other applicable regulationsTime, cost and quality metrics in Clinical Development as well as Finance and budgetingClinical trial cycle timesKey CompetenciesStrong networking, relationship building and management (internal/external especially investigatorsAnalytical and problem solving skillsPresentation and negotiation skillsExcellent oral and written communication skills (German and English)Ability to work under pressure, resilience, flexibilityHJEU2017

Locations

Germany Munich

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