Associate Director Evidence Generation Operations

Associate Director Evidence Generation Ops

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

Provides visibility and oversight of execution across Medical Affairs Evidence Generation activities for the assigned therapeutic area. Accountable for providing visibility into the planning & progress of all research activities across Regions/Geographies. This includes all Medical Affairs Company-Sponsored Studies, Investigator Sponsored Research, partnered alliance research and Collaborative Research. As an extended member of the Core Medical Team (CMT) they will be accountable to provide the leadership and direction to ensure appropriate visibility on activity execution including bringing forward delays for risk mitigation discussions. The position creates a single point of operational contact on Medical Affairs Evidence Generation activities within the therapeutic area.

Essential Job Responsibilities:

• Responsible for coordination of the Medical Affairs Study and Protocol Review Committees and Benefit Risk Team.
• Integral contributor to the Evidence Generation discussions at the Core Medical Affairs Team (CMT) to understand the evidence gaps and feasibility of potential Evidence Generation activities that appropriately address prioritized gaps
• In collaboration with regional MA Evidence Generation Operations colleagues, accountable for study execution oversight and on-time delivery of planned milestones while ensuring compliance, quality, and meeting budget expectations.
• Integral in setting the operational strategy for Evidence Generation for a Therapeutic Area.
• Accountable for budget oversight within assigned Therapeutic Area, and resource management, as well as identifying areas for potential cost optimization
• In collaboration with regional MA Evidence Generation Operations colleagues, responsible for the oversight of risk mitigation, risk management and contingency plans at a TA level.
• Partners with CMT Lead and CMT members to be operational partner in helping team to develop best approach to close prioritized evidence gaps
• Maintains single, consolidated, accurate view of Evidence Generation activities for assigned TA
• Facilitates annual Evidence Generation planning activities within assigned TA, including new research proposals and annual revision of ISR Areas of Interest/Non-Interest
• Identifies non-performing studies to return to Medical Affairs Committee (MA-C) for evaluation and alignment on action planning
• Coordinates consistent aligned approach for Evidence Generation activities to proceed to governance committees
• Responsible for all partner related Evidence Generation activities and processes, as applicable
• Create and communicates timely, accurate, and transparent updates and reports to Operational Excellence Leadership Forum, Evidence Generation Operations Matrix Team and Medical Affairs Committee/Leadership Team
• Maintains effective cross functional link and collaboration with Clinical Science / Development and partners on M&D projects, as applicable
• Leads initiatives to introduce best practices, ensuring adoption and execution of GCP/ICH, GPP and other applicable regulations/guidance governing data generation activities in the department
• Accountable for study audits and Inspection coordination and oversight within their assigned Therapeutic Area
• Lead or participate in process improvement and quality-related initiatives associated with study execution and deliverables; participate in establishment of best-in-class processes and standards for study conduct
• Partners with M&D Finance to ensure proactive oversight of budgets across all Evidence Generation activities for assigned TA and both accurate and timely reporting to senior leadership

Quantitative Dimensions:

$25-30MM (Company-Sponsored Studies, ISRs, CRs)

Organizational Context:

• Reports to Senior Director, Global Head, Evidence Generation Operations
• Participates in both the Study Operations & ISR matrix teams