Associate Director, Evidence Project Management

About the role

The Associate Director, Evidence Project Management (AD EPM) within the Medical Evidence Delivery Team of the Oncology Business Unit (OBU) is responsible for leading the operational planning, delivery, oversight and budget management of company sponsored evidence studies and/or Early Access Programs (EAPs) within the assigned therapeutic area (TA).

Responsibilities

• Partner with direct manager, ensuring provision of expertise and operational input into the programs (Governance interaction, study protocol, etc)
• Collaborate with Dir EPM / Sr Dir EPM and provide adequate input to enable effective CRO selection
• Serve as the reference point for communication and escalation of issues
• Mentor, coach and support the study team members
• Lead a cross-functional study team in accordance with EMPOWER to ensure study progress as planned and driving achievement of breakthroughs
• Be primary AZ point of contact for the CRO Project Manager to secure study delivery according to set criteria
• Ensure the appropriate level of oversight of the CRO is maintained and documented throughout the study lifecycle in alignment with relevant AZ SOPs and guidelines (e.g. Sponsor Oversight Plan, Description of Services)
• Co-ordinate/lead timely contributions of AZ core/extended members
• Collaborate with key partners cross-functionally, and/or external partners, to identify, handle and resolve issues affecting study delivery
• Review protocol drafts and input operational perspectives/content into document and authoring team discussions
• Provide input into and/or quality review and hold accountability for the development of crucial study level documents (e.g. ICF, study plans and guidelines), delegate responsibilities among the team as appropriate
• Ensure all required External Service Providers (e.g. CROs) are engaged at the study level (including execution of relevant vendors contracts) and are performing to contracted goals, timelines and budget, as well as adequate oversight is documented
• Responsible for study budget management through the study lifecycle and for providing budget progress updates to Dir EPM / Sr Dir EPM including any financial risks and mitigation plans (as part of the ongoing study change control process)
• Maintain/report accurate cost forecasts throughout study, lead study spend within available budget & agreed tolerances
• Responsible for setup of the study cost tracker
• Monitor study risks throughout delivery and oversee team in the development/implementation of mitigations and contingencies
• Oversee study/EAP level performance against agreed upon plans, achievements and key performance metrics, EAP exit strategy
• Identify and report quality issues that have occurred within the study, proactively communicate findings and corrective action plans (CAPA) to relevant collaborators
• Supervise periodic TMF QC and responsible for review of relevant sections/documents in accordance with SOP
• Specifically in the EAP space if assigned to, in addition to the above: Lead program planning, set up, implementation and delivery of EAP in collaboration with local/regional/global medical and market access teams
• Participate in operational governance activities related to agreed CRO strategic and operational governance principles
• Perform vendor oversight to ensure EAP delivery to time, cost and quality
• Manage resolution of program specific issues and partner concerns with internal and external team members

Requirements

• Bachelor’s degree required preferably in medical or biological science or equivalent by experience
• 3 years of experience in extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area
• Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools
• Ability to effectively work with Clinical Research Organizations/External Providers
• Leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
• Consistent record in interacting widely and effectively within the company across regions, functions and cultures
• Persuasive communicator in English with a proven track record to work collaboratively in a multi-cultural environment
• Experience and knowledge within compliance management of Early Access Program
• Advanced degree in medical or biological sciences or field associated with clinical research
• Experience of incorporating digital health and patent centric strategies into clinical studies

Desirable

• Experience in compliance management of Early Access Program
• Advanced degree in medical or biological sciences or field associated with clinical research
• Experience of incorporating digital health and patent centric strategies into clinical studies