Fusion – Sub-Chapter Lead Clinical Development Nucleus II (m/f/d)

Job title:

Fusion – Sub-Chapter Lead Clinical Development Nucleus II (m/f/d)

Company

Roche

Job description

Diabetes is a pesky monster — and that’s putting it mildly. If you’re serious about helping us face it head on, come join us! For a behind-the-scenes look, check out our , and to see what makes mySugr and Roche tick.Here’s what we’re looking for:Your positionAs a Clinical Development Sub-Chapter Lead – Nucleus II (m/f/d) you will be responsible for coaching and developing the capabilities of Global Clinical Development Leads, who specialize in clinical evidence and medical safety for medical devices to deliver on network priorities and regulatory requirements. You will liaise with the other Sub-Chapter leaders to improve assets associated with the sub-chapter, such as processes, product standards, tools.The opportunityManage the hiring, onboarding, promotion, coaching and mentoring of subchapter members and promoting skill and career development of people within the subchapter to meet future needsProvide demand analysis and supply planning in the Sub-Chapter in close alignment with the functional partners (FPs) and CDMA Project Management as per CDMA operating model & playbookLiaises with other SCLs and the CLs to understand, share, and develop best practices as well as medical and scientific expertise. Oversee generation, interpretation and documentation of clinical evidence, medical safety and medical risk assessments during product design and development and post-launchDevelop and implement Functional Excellence strategy for subchapters together with the SC, Medical Affairs and Clinical Operations and provide leadership and subject matter expertise for the co-creation of the clinical development strategies and integrated evidence plans (IEPs) for new and existing product in dedicated disease areaProvide expertise and thought leadership to Squad Leads, Indication Leads (ILs), and NLs on key decisions to achieve the RDS, RIS, and Roche vision across technologies and function as a senior consultant and provides scientific and medical subject matter expertise and thought leadership to the disease area strategy and key organizational decisions to achieve the RDS, RIs, and Roche vision across technologiesProactively partner with Squad Leads, ILs, and NLs for the pipeline generation of novel diagnostic solutions and medical devices by designing and driving exploratory and clinical development strategiesEstablish collaborations with relevant functions, including R&D, Regulatory Affairs, Pre and Post Market Quality, Business, Global Access and Policy, partnering with Roche Pharma/Genentech, the regions, affiliates and external subject matter experts as neededContinuously seeks to bring innovative and cost-effective evidence generation strategies to optimize resourcesYour profileEducation: MD/ PhD / PharmD, Senior academic professional experienceExperience: 10+ years of experience in the medical device and/or diagnostics industry or a related field in business related functions with relevant experience in clinical research and development, regulatory and compliance / medical safety requirements.Languages: Fluent in English on a business level with excellent verbal and written skills is required; German is a plus; other languages welcome, but not required.Proven ability to lead with creative attitude, very high self-awareness and being a coach and a mentor to other leaders and partnersManagement/leadership experience with oversight of clinical data and medical safety related work with a main focus on medical devices and direct to patient solutions as well as software as a medical device that enables these solutionsBroad expertise in disease areas for the subchapter is requiredExpertise in med tech patient safety processes is requiredExpertise in IVDR, MDR and FDA regulatory requirements is requiredDeep / broad knowledge in planning and designing clinical evidence generation activities and understanding of the diagnostics industryTravel % required: up to 15% depending on the location of the position and business needsLeadership Skills:You are also responsible for building, and then providing effective leadership for a global team. Doing so in a manner that is consistent with the Roche Values and leadership capabilities. You will seek to inspire and lead your program leadership team to create transformative solutions, and to influence their prioritization and uptake in the wider organization, in order to ensure that customer solutions are at the forefront to both the Near Patient Care Customer Area and Roche Diagnostic Solutions generally and deliver its optimal contribution to the Roche Diagnostics Vision..This leadership expectations requires:● Put patients first● Follow the science● Act as one team● Embrace differences● Accelerate learning● Simplify radically● Make impact now● Think long termPreferred candidate identified.Please upload your resume in English. Additional documents will be requested if required.Roche is an Equal Opportunity Employer.

Expected salary

Location

Wien

Job date

Thu, 25 Jul 2024 22:24:02 GMT

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