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 biopharmaceutical companies. We’re also a Great Place to Work. At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Role Description

The Site Management and Monitoring (SMM) organisation, with staff across the globe, is responsible for global site management delivery across the Oncology portfolio.The Oncology SMM Senior Director Country Head (OCH) Is head of the oncology country SMM management team and acts as the first point of contact for the Global or OncologySMM Hub Head.  The OCH is accountable for oncology clinical study strategy planning and execution and delivery of committed oncology clinical studies according to agreed resources, timelines, budget and quality in compliance with regulatory requirements and AZ procedural documents.  The OCH is responsible for ensuring consistent, transparent communication to Biopharma SMM Country Head and regularly interacts with Medical Directors within the cluster as needed. The OCH is locally responsible for line and resource management of operational staff within their country or cluster, reports to the Head of Global Oncology SMM or Oncology SMM Hub Head, and is a member of the Oncology Regional Leadership Team or the Oncology SMM global LT. The OCH may manage CQADs and line managers. In larger affiliates that can support more than one line manager, the OCH might line manage both operational staff and one or more Associate Directors or Directors with line management accountability. The OCH is accountable for identifying opportunities and feasibility of oncology clinical studies within their country or cluster. The OCH will ensure appropriate resource planning and skills management within their country or cluster. The OCH will lead, develop and give guidance to their team to enable local high-quality performance, productivity and delivery of committed global R&D and other oncology interventional studies.

Typical Accountabilities

  • Accountable for delivery of oncology interventional studies according to agreed quality, resources, budget and timelines being in accordance with Oncology R&D, LDO Clinical Operations, Development Operations and Oncology SM&M objectives

  • Act as a member of the local Medical Directors Leadership Team as part of role as SM&M business partner to the Medical Director, and can integrate the local LT of the MC if appropriate

  • Responsible for effective resource allocation of the different functions within Oncology SMM team to ensure proper high quality delivery of committed studies, including local identification of any need for in/outsourcing to CRO or need to use flexible sourcing and discussion with Business Planning & Operations Senior Director

  • Proactively identifies and facilitates resolution of complex study & team, people problems and issues

  • Ensure compliance with all locally and globally used systems such as VCV, MyTime, ACCORD, etc.

  • Contributes to creation of optimal patient recruitment strategy

  • Ensure accurately and timely reporting of adverse events

  • Works actively to create professional relationships & collaborative networks with investigators and AZcolleagues

  • Support staff to deliver committed oncology clinical studies according to agreed resources, budget and timelines andwith high quality performance. Provide expertise and guidance to support direct reports with proactive problem/riskidentification, solution building and issues resolution to facilitate achievement of objectives on time and to appropriatequality

  • Collaborates with other OCHs in the region (in coordination of global/regional office) to ensure leadership of oncologyprogram and study level feasibilities. Ensure that regulatory and medical inputs are also included as needed

  • Collaborate in global/regional discussions and give advice on global/regional specific questions regarding protocol

  • Good insight into local regulations

  • Collaboration with local decision makers (MoH, regulators, IRBs, etc)

  • Support as per need activities in the preparation, initiation, monitoring and closure for agreed centres in oncologyclinical studies

  • Ensure that CRO consultants and staff receive appropriate training in related AZ procedures, processes and systems

  • Responsible for assigned budget

  • Promote and encourage communication within and across departments

  • Provide performance management, performance assessment and reward proposals for direct reports. 

  • Maintain an environment that attracts, develops and retains highlight qualified employees. Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE

  • Support and comply with Continuous Assurance activities, reporting and actions as required

Education, Qualifications, Skills and Experience

Essential

  • Bachelor’s  degree or equivalent qualification in relevant scientific discipline

  • Extensive experience in Development and Patient Safety

  • Relevant Pharmaceutical experience

  • Leadership experience in a complex environment

  • Ability to effectively communicate with stakeholders within AstraZeneca

Desired

  • PhD in scientific discipline 

  • Expert reputation within the business and industry

  • Extensive knowledge of the latest technical and regulatory expectations

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.