Astellas Pharma Associate Director Evidence Generation Ops in Northbrook, Illinois
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. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid 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:
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
- $25-30MM (Company-Sponsored Studies, ISRs, CRs)
Reports to Senior Director, Global Head, Evidence Generation Operations
Participates in both the Study Operations & ISR matrix teams
Educational Background: Bachelor’s in Sciences
Years of Experience: > 8 years of operations experience in pharma industry (or related) with most of this time spent in clinical program management, > 3 years’ experience leading teams as part of project management, process improvement or strategic planning.
Significant experience of leading/overseeing Evidence Generation activities (MA sponsored studies, collaborative research and ISRs) and associated budget management
Extensive experience working within a medical affairs organization and a thorough knowledge of medical affairs processes and research types
Clear demonstration of strong negotiation and influencing skills that lead to change
Proven ability to analyze, assimilate and interpret data then extrapolate key points and facts to present to Senior Leadership
Excellent project management skills, including risk assessment and contingency planning
Demonstrated ability to work independently in a proactive manner
Strong collaborative skills, ability to build partnerships and alliances
Ability to work effectively in a matrix team
Able to demonstrate strong negotiation skills with internal departments, and 3rd party vendors
Proven leadership abilities
Generous Paid Time Off options, including Vacation, Sick time, national holidays, two Heritage Days, and Summer and Winter Breaks
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
Category Operational Excellence
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans