The Associate Director, Study & Data  Solution Implementation is a member of the S&DS Leadership Team and is accountable for providing the Strategy Vision and Leadership of Services that support the Unified Clinical Platform  including eCOA and patient engagement tools to the Study and Data Solutions function and for driving delivery of solution provision to R&D to meet internal customer needs and enable optimal end-to-end delivery of clinical studies.

The Associate Director has direct line leadership and accountability for a function delivering customer-focused support and services for the wider organisation, with approx. 2-3 Managers and a total of 15-20 direct reports.

The Associate Director is accountable for the identification, definition and delivery of transformative improvements in end-to-end clinical study delivery, utilising tools and techniques to achieve continuous improvement and value creation such as Kaizen/Lean Six Sigma in conjunction with partner organizations internally and externally within their respective category. This includes the creation of new central services and solutions as identified by the business and in line with transfer of new future-sustainable operational ways of working following transition from Digital Health

S/he leads and drives continuous improvement and innovation via industry-leading developments in line with the Development Operations business objectives, in partnership with but not limited to, all SMO functions, SMM, Procurement, Alliance Management, Biometrics Operations and Digital Health and contributes to functional, cross-functional and regional initiatives.

The success of the role is also strongly governed by the strong leadership of external partnerships with various suppliers working together to continually identify new and better ways to provide successful and effective central services for study teams and the wider business needs. This includes the development of the supplier engagement models with Procurement and Alliance Management, and the continuous provision of KPIs via data, trends and analytics of the success of the suppliers.

Strong organisational change management, influencing, communication and process adoption skills are a critical requirement, ensuring the breadth of central services including data solutions, via a large selection of processes and systems, are successfully implemented in a consistent manner across both TAs and all expected end users.

Ongoing review of industry best practice, innovation and regulatory landscape is critical for AZ’s success in the identification and implementation of the many and various data and system central solutions. Organisational construct, methodology of system application and framework around the processes of use and conduct will require continuous assessment for future sustainability.

Typical Accountabilities

1) Category Leadership and Strategic Oversight (processes, systems and central services):

As the primary point of contact for a designated component of the Clinical Operations process, technology and central service portfolio within each Category:

• Provide strategic oversight of the Enablement personnel, processes, technology and central services within the allocated Category
• Accountable for the design, development, implementation, maintenance, continuous improvement and ongoing customer support for the processes, technology and central services within the category, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies
• Accountable for the effective and timely communication of information, and for the provision of high quality training for all new and updated processes, systems and central services within the assigned Category
• Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the Category. Work with Enablement Leadership and Clinical Operations Leadership to prioritise the needs and resources required to deliver solutions, and provide feedback and clear rationale for any areas that will not be addressed
• Act as the primary point of escalation for Enablement personnel for any risks and issues identified within the assigned Category
• Member of Steering Committees and Governance Teams relating to processes, technology and central services within the Category. Support Enablement personnel with Vendor Management and issue escalation
• Work with Enablement Leadership to define and monitor key performance indicators to evaluate the overall performance of the processes, technology and central services within the Category and across the end-to-end clinical development value chain. Analyse Category performance and trends, share performance information and work with Enablement personnel to identify and implement solutions that improve business performance
• Oversee the delivery of Corrective and Preventive Actions to time and quality, and act on data or trends identified through the Quality & Risk Management process.

2) Business Process Management and Oversight:

• Delivers an integrated and holistic approach to procedural development, maintenance and improvement for Clinical Operations. Works with Category Leaders, Head of Process, PES personnel and with other functional Process Owners to ensure cross-functional alignment and inspection readiness at all times

3) Global Line Management:

• Provides global management and leadership to fulfil global management accountabilities and local employment law requirements (Global - in Clinical Operations Enablement locations)
• Attracts, develops and retains top talent and actively works to promote team building and morale within the department
• Provides direction, real time situational mentoring, career development guidance, and coaching as appropriate
• Provides performance management, performance assessment and reward and recognition proposals for direct reports
• Develops and nurtures future AZ managers by leading and driving the capability development of the function. Builds a sustainable capability development framework and ensure individuals are equipped with the right skills and capabilities to deliver.
   

4) Business Performance Leadership and Oversight:

• Coordinates the tracking of demand and capacity of resources, and of overall performance within his/her team
• Works with senior stakeholders within GMD and Clinical Operations to connect demand from drug projects, studies and improvement projects with resource allocation and work prioritisation

5) Functional Partnering:
Act as the primary point of contact for a Functional Leadership Team:

• Understands the processes, technology and services the function relies on, their needs and pain points. Uses this knowledge to remove barriers and identify opportunities for improvement. Represents the assigned functions needs in improvement work prioritisation, communication and implementation planning
• Ensures the effective resolution of process, technology and service risks and issues that impede the functions progress and effective delivery. Identifies and engages with the right process, technology and service experts, and expertly utilises escalation routes and governance bodies to gain traction and deliver rapid solutions.

People Management Responsibility

• Direct reports: 2-3
• Indirect reports: 15-20
• Approximate number of people managed in total (all levels): Up to 20 total in department

Education, Qualifications, Skills and Experience

Essential

• Master of Science in an appropriate discipline or equivalent experience
• Proven team or leadership experience, preferably on a global scale, identified through examples over 7 years+ experience.
• A deep understanding via 7+ years of pharmaceutical industry experience, of the systems, business processes, technology, clinical trial information, regulations and guidelines impacting the drug development process
• Experience of engaging with external partners and vendors for the implementation of industry leading solutions.
• Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment
• Ability to identify opportunities, lead and foster cross-functional collaboration, and to work across boundaries to increase performance in the end-to-end clinical development value chain
• Experience in working successfully and collaboratively in the delivery of process implementations within a complex cross-functional network.
• Demonstrated ability through examples, to lead and manage through change, and see change as an opportunity to improve performance and add value to the business
• Ability to influence and negotiate at all levels to bring business benefit and customer satisfaction, and to gain the trust and respect of the Senior Leadership Team in PES
• Demonstrated project management skills and proven skills to deliver to time, cost and quality in complex projects,
• Demonstrated excellent written and verbal communication and influencing skills, negotiation, presentation, knowledge transfer (mentoring), collaboration, problem solving, conflict management and interpersonal skills

Desirable

• Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement
• Interest and identification of future ways of working in a changing industry for the implementation of agile R&D such as implementation of automation or data science

Key stakeholders and relationships

Internal (to AZ or team)

• Study and Data Solutions Leadership Team
• Development Operations functions: SMM, Biometrics Operations, Alliance Management, QTRM
• Biopharmaceuticals and Oncology SMO (early & late)
• Digital Health
• Quality Assurance
• Procurement
• SEUIT
• ESteering Committees and Governance Teams set up and impacted by implementation and ownership of Business Processes.

External (to AZ)

• External Technology Provider e.g. ERT, Medible, UMotif and others, CROs
• Functional service providers

Date Posted

Closing Date

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.