SENIOR DIRECTOR, DEVICE & DIGITAL SAFETY - CMO

About AstraZeneca   AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases.
But we’re more than one of the world’s leading pharmaceutical companies.
At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.
The Senior Director, Device & Digital Safety sits within Global Patient Safety - Operations, Technology & Analytics and Chief Medical Office.
The successful candidate will have oversight of Patient Safety’s input to digital and device development, implementation, investigation and maintenance through management of capacity and delivery strategy.
They will lead the design, development, implementation, maintenance, continuous improvement and ongoing customer support for the processes, technology and services within the digital & device area, and ensure compliance with applicable industry regulations and AstraZeneca Global and Local Policies.
They will be a core member of OTA Leadership team and act as deputy for the Head of PV Management, as needed and ensure that all internal and external relationships and interfaces are managed effectively.
Key Responsibilities.
Accountable for supporting the strategic aims and annual objectives for the OTA that originate or relate to Patient Safety aspects of Digital and Devices   Engage with key collaborators to drive the strategy, development and continuous improvement of processes, technology and services within the digital and device area.
Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the area.
Work with Line Managers and Leadership to prioritise the needs and resources required to deliver these requirements and provide feedback and clear rationale for any areas that will not be addressed.
Ensures that internal processes are fit for purpose and maximise the effectiveness of the outsourced delivery, working with relevant collaborators to improve processes.
Partner with Systems team to ensure an integrated and broad approach to device & digital processes and systems.
Partner with LP team to ensure consistent, manageable and delivery contracts   Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers.
Responsible for delivery of major / transformative improvements in PV and Patient Safety delivery, utilising tools and techniques to achieve continuous improvement and value creation.
Sponsor or lead improvement projects as needed.
Lead team of staff providing training, delegation and coaching as needed.
Act as the primary point of escalation for personnel for any risks and issues identified within the assigned area.
Establish a global mind-set to systematically gather, consolidate & communicate regulatory authority and industry intelligence for the proactive continuous improvement of activities required to ensure license to operate and regulatory compliance.
Ensure technical and scientific excellence of PV/regulatory processes related to digital and devices.
Support Executive Director to deliver GPS OTA and cross functional initiatives   Device & Digital Responsibilities.
Establish Global Patient Safety Operating model for delivering Patient Safety’s input to digital and device, including capacity management   Lead and represent Global Patient Safety on cross-functional digital and device enterprise committees and forums   Collaborate with Global Patient Safety Therapeutic Areas to support the implementation of digital and devices in medicines and lead the specific digital and devices contributions to the development programs/projects   Lead PS collaborations across the enterprise, specifically Device Quality & Operations, Device Regul atory and Device Development to deliver AZ devices products   Contribute to enterprise device and digital product forecasting and capacity requirements   Responsible for oversight of medical device, digital health and in-vitro diagnostic regulations and local requirements that impact Patient Safety and/or require implementation   Management of Global Patient Safety’s input to procedures and processes owned & authored by other functions that include digital & devices language impactful to Global Patient Safety.
Lead and develop a diverse team, consisting of two broad groups;   Process and Expert Advice     Device Development & Digital Health Solutions    Requirements.
University degree or equivalent qualification in relevant scientific field   Extensive experience in pharmacovigilance and regulatory compliance within a pharmaceutical, clinical, regulatory or pharmacovigilance environment   Experience with the application of digital to clinical trials and the post-market setting   Experience with device development   Comprehensive knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals   Experience with outsourcing and working successfully with external partners   Ability to manage multiple partners   Ability to apply strategic direction to a team or project   Extensive knowledge in project management skills, specifically leading teams   Experience in line management on a regional/global basis   Understanding of governance processes   Desirables.
PhD in scientific subject area   Knowledge of new and developing regulatory and pharmacovigilance expectations   Key capabilities.
Understanding of governance processes   Process improvement (eg Lean methodology)   Financial awareness   Ability to influence without authority   Open to multiple perspectives   Balanced perspective   Solution focused   AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.