Clinical Program Director, Early Cvrm Clinical Development
AstraZeneca AB / Kemiingenjörsjobb / Göteborg
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hela Sverige At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
We are recruiting two Clinical Program Directors (CPD) within the Cardiovascular, Renal & Metabolism (CVRM) team. This role will ensure that each assigned clinical program is delivered to time, quality and cost, and provide strategic input and final feasibility view into design of the clinical program. The CPD plays a key role in the work required to determine possible program design options, mainly in early clinical development programs. The focus is across the program level collaborating with the Development Operations organization, Program Team colleagues, and all other functions that are key to the development of a compound.
The role is located at our site in Gothenburg, Sweden (our sites in Cambridge, UK or Warsaw, Poland would also be an option).
Responsibilities include:
You will be accountable for translating science into crisp and robust clinical development plans, including operational design options in collaboration with the Senior Medical Director. Accountability for the clinical program strategy, including innovative ways to delivery, e.g., new delivery platforms and technology to ensure patient engagement, recruitment and retention will also be part of the role. You will be responsible for leadership and oversight of program strategy activities within each assigned program and provide strategic and operational input to cross-functional program development plans and accountable for cross-functional leadership roles as delegated from the Global Project Team, e.g., leadership of cross-functional global project team activities.
You will provide expert clinical operational input into: Target Product Profile, Clinical Development Plan, Study Synopsis, Clinical Study Protocol/Reports, etc. to ensure seamless delivery of programs through effective collaboration. In this role, you will collaborate with Dev Ops on the process to ensure timely selection of an appropriate delivery model including selection of external providers for program/study specific tasks as well as supporting the operational management and oversight of the external providers. Responsibility for development and management of contingency risk plans within each assigned clinical program to ensure operational delivery to quality, budget and timelines, issue escalation and resolution, will be part of the role as well as contributing to scientific interpretation of clinical data and ensuring consistent quality practices in alignment with the highest ethical standards, GCP, ICH Guidelines, etc. You will be responsible for ensuring timely compliance with AZ-wide governance controls and contribute to driving standard methodologies and support process-related improvements and workstreams.
Essential Requirements:
• Advanced degree in medical/biological science is preferred
• At least 15 years global drug development experience from a variety of related roles
• Program level experience across product life cycle and across multiple therapeutic areas (Cardiovascular, Renal, Metabolism is strongly preferred)
• Leadership and strategic influencing skills with the ability to motivate team members and build cross-functional teams
• Validated ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements
• Experience of clinical program management and use of project management techniques in complex projects, including resourcing and financial management
• Experience in clinical trial methodology with ability to deliver differentiated options based on sound knowledge of clinical operational delivery, including time, cost and quality
• Validated experience of leading delivery through selection and collaboration within globally matrixed teams
• Willingness to travel both domestically and internationally
• Possess positive change management skills, at all levels (individually, team and the business), seeing change as opportunity to improve performance and add value to the business
Desirable Experience:
• Program management qualification/certification. Experience in variety of organisations and countries
• At least 12 years' clinical operations experience
For more information about this position, please contact hiring manager Redge Santos at
redge.santos@astrazeneca.comWe look forward to your application (CV and Cover letter) no later than April 12th 2020, and applicants will be reviewed continuously and the position may be filled prior to last application date.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2020-03-23ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2020-04-13
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-077820".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 5163001
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