Evidence Delivery Associate Director
Job Type: Full time
Oncology Business Unit Medical (OBU Medical)
OBU Medical ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (AZ) therapies and support our internal stakeholders with medical insight and expertise. OBU Medical provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. OBU Medical aims to lead AZ in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.
OBU Medical Evidence Delivery is accountable for the operational delivery of global strategic studies required to generate the evidence to build the confidence on AZ therapies, the delivery of Early Access Programs (EAPs) and the coordination of externally sponsored research (ESR’s) conducted by external sponsors that endorsed by Global Product Teams and Global Medical Teams.
We are looking for Evidence Delivery Associate Director’s (EDAD’s) to work in the Astrazeneca Sponsored Studies space at this time, but opportunities may exist for getting exposure to EAPs and ESR oversight in the future.
Evidence Delivery Associate Director (EDAD) role
In the AZ sponsored studies setting the EDAD is a program managerial role accountable for the operational planning, delivery, oversight and budget management of more than one company sponsored studies. The EDAD will oversee and support a number of project managerial teams comprising of an Evidence Delivery Manager (who will be primarily responsible for operationalization of each study), an Evidence Associate Manager (EDM) and an Evidence Associate (EA).
The EDAD will drive forward program managerial decision making, ensure study teams have clear strategic direction, manage program level stakeholders and coach/support individual study teams in more complex aspects of study delivery. In doing this the EDAD will work closely with their respective EDM’s and the scientific study leader who is responsible for all scientific aspects throughout all stages of the study (epidemiologist for observational studies, Medical Affairs Leader for interventional studies). EDAD’s will support OBU Medical Evidence Delivery continuous improvement activities by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials.
Specific responsibilities of the EDAD for Astrazeneca sponsored studies
- Program Managerial oversight of more than one study
- Program level Stakeholder Management
- Vendor oversight
- Provision of clear strategic direction to study teams throughout the course if a study through dialogue with program level stakeholders
- Provision of operational input into the development of business cases during annual and ad-hoc planning and subsequent Study Design Concept (SDC) generation, including the coordination of feasibility assessments performed by AZ or my partner ESPs.
- Coordination of Study Design Concept generation in line with agreed plans.
Specific accountabilities of the EDAD for Astrazeneca sponsored studies
Accountable to the business for ensuring study teams deliver the following to agreed expectations, contributing to activities and coaching team members to deliver when necessary:
Protocol development & Study Governance
- Drive the process of coordinating protocol development by ensuring input of all relevant cross functional (internal) and external stakeholders.
- Responsible to provide input on operational feasibility of the protocol
- Coordinate all internal, study governance processes
- Coordinate all internal, study governance processes
- External Service Provider Management including selection of External Service Providers (ESPs), including Clinical Research Organisations (CROs)
- Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and ensure that study delivery is within time, cost and quality limits
- Manage study specific issues and escalations with ESPs/CROs.
- Set up study team and manage study sourcing
- Effective collaboration with the scientific/medical counterpart, the Epidemiologist/Medical Affairs Leader (MAL) respectively, as well as other internal cross functional global roles
- Report study updates from a time, cost and quality perspective to internal stakeholders
- Clarify and document an effective communication approach, as well as roles and responsibilities between the OBU Medical stakeholders, local AZ and External Service Providers.
- Ensure appropriate level of involvement of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during study design and delivery
- Develop and maintain the overall study budget (internal and external study costs)
- Keep transparency on study budget and changes through relevant systems and platforms (Planning Performance and Control (PPC) meetings) and obtain approval for budget changes
- Work with procurement on study agreement and manage subsequent out of scope changes for ESP/CRO. Manage and reconcile Contracts, POs and invoices. Financial audit readiness and Sox attestation
- Deliver studies to agreed timelines (scorecard), within the approved budget and according to AstraZeneca quality standards.
- Ensure global oversight over the operational study start up, implementation and closure and ensure inspection readiness
- Lead study related change management within business strategy, s.a. assessment of scope changes.
- Ensure Compliance with AZ Procedural Documents, Standards and Policies, international guidelines and local regulations at any time, and report compliance breaches
- Undertake feasibility assessments with internal and external stakeholders
- At least 3 years experience project managing/leading study teams in the set-up, delivery and reporting of large multi-national interventional company sponsored clinical or medical evidence generating studies
- At least 8 years of relevant clinical/medical study management experience in the pharmaceutical industry, with a good understanding of the drug development process
- Previous demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
- Good Project Management knowledge and previous demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
- Excellent knowledge of the external regulations e.g. GCP/ICH and Astrazeneca’s SOP’s pertaining to the delivery of interventional and observational studies
- Proven ability to work effectively with Clinical Research Organizations/External Providers and to interact widely and effectively within the company across regions, functions and cultures.
- Bachelor’s degree (preferably in medical or biological science) or equivalent by experience.
- Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
- Open to periods of travel
- Oncology experience. Experience leading/project managing oncology clinical/medical studies.
- Experience in the delivery of Real World Evidence generation studies
- Advanced, post-graduate degree
- Project Management Certification
- Experience in all phases of a clinical study lifecycle
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.