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 10-12 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 Regulatory 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