Executive Director, Medical Operations
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Northbrook, IL 60065
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There’s something special about working at Astellas. It’s reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing an Executive Director, Medical Operations opportunity in Northbrook, IL.
Purpose & Scope:
The Executive Director, Medical Operations provides regional leadership and strategic direction for Project Management, Clinical Operations, Health Economics & Outcomes Research (HEOR) Operations, Investigator Sponsored Research (ISR), External Medical Education, Internal Communications, Systems, Contracts, Training and Process Optimization for the Medical Affairs Americas organization. This encompasses support for all Astellas therapeutic areas; and is accountable for the operational aspects of all MAA strategies and related deliverables, including core medical plans, budget and timelines. The Medical Operations function is responsible for managing all activities outlined in the core medical plans, facilitating execution of such plans and ensuring operational excellence. The Medical Operations function is also responsible for the regional execution of all MAA sponsored and external research and medical education activities. This includes appropriate management and documentation for Astellas sponsored studies, Investigator Sponsored Research and grants and sponsorships. The Executive Director is also responsible for leading Business Operations activities which span overall MAA group strategies, Training and Process Optimization, Communications, Medical Affairs-related systems and the successful implementation of the annual MAA Forum. The Executive Director is accountable for ensuring audit readiness and compliance with Astellas quality standards and requirements as well as any relevant external regulations and standards.
The Executive Director facilitates effective coordination and collaboration with global and regional departments within Medical Affairs as well as more broadly across Medical & Development (M&D); and works closely with Corporate Communications to develop and align internal MAA communication strategies.
Essential Job Responsibilities:
- Lead and support all MAA operational activities required to meet MAA annual objectives, including accountability for the department’s annual, midterm, and long-term strategic plans, product core medical plans, budget development and management, systems, and communications activities (e.g. SharePoint, Newsletter, other)
- Accountable for the execution, reporting, documentation, budgeting and resourcing of data generation activities in partnership with Therapeutic Area (TA) Medical Lead and Health Economic Outcomes Research lead. Data generation activities include MAA company sponsored trials, Investigator Sponsored Research, Collaborative research and retrospective and prospective HEOR studies
- Develop and drive operational excellence strategies, processes, metrics, systems and tools to support successful planning and execution of all MAA tactics
- Develop and implement training solutions, SOP harmonization strategies and process improvements across MAA; ensure training and process activities are compliant with M&D and Astellas requirements and standards
- Responsible for oversight of independent medical education strategy and execution including compliant review, approval and documentation of all grants across MAA region (e.g. external regional grant platform, J-Sox controls and internal and external regulatory, legal and compliance guidance’s)
- Align with Quality Assurance (QA) stakeholders to define QA/audit needs for MAA. Provide direction, develop and monitor processes to maintain audit readiness, and address and close out audit findings/CAPAs in collaboration with internal stakeholders
- Provide guidance and oversight of appropriate overall metrics and effectiveness measures across MAA to ensure continued improvement and appropriately demonstrate value of MAA activities to internal stakeholders
- Develop strategy and execute internal communications plan aligned with Corporate Strategic Plan and Medical Affairs Value Narrative to demonstrate MAA value and enhance employee engagement
- Lead, develop and manage Medical Operations team ranging from analyst to Sr. Director of 20+ members plus contractors; ensuring effective use of situational leadership, employee engagement and people development skills
- Build strategic relationships with key internal stakeholders across regions and in relevant functions within M&D and Americas Operations
- Partner with Finance, Legal and Contracting to oversee, develop, and manage CRO, alliance and vendor partner strategies in support of MAA
- Cultivate collaborations and relationships with external organizations to position Astellas as a competitive and responsible world class pharmaceutical company
The Executive Director Medical Operations provides operational strategy and execution for the entire portfolio of products and for all TAs in the MAA region. The Executive Director Medical Operation oversees, tracks and manages the overall MAA operational budget of up to $100M and is responsible for operational aspects all clinical, partner and HEOR studies, up to 100 ISRs, and up to 150 Medical Education Grants annually. The Executive Director in conjunction with the TA VP is accountable for up to 10 Core Medical Plan and related deliverables and will demonstrate solid leadership and executive presence with internal and external stakeholders.
The Executive Director Medical Operations reports to the Senior Vice President, Medical Affairs Americas and manages a department of up to 20+ employees, plus Clinical Operations contractors. Direct reports include: Senior Director Business Operations & Strategy, Director Project Management, Director Independent Medical Education and Director Process and Training. The Executive Director will have matrix leadership responsibilities across the Americas region, Medical Affairs and Medical & Development including core membership in global committees. The Executive Director will collaborate with the following colleagues:
Strategy, Director Project Management, Director Independent Medical Education and Director Process and Training. The Executive Director will have matrix leadership responsibilities across the Americas region, Medical Affairs and Medical & Development including core membership in global committees. The Executive Director will collaborate with the following colleagues:
- MA: VP/Executive Director/Senior Director in TAs and HEOR in the region, sub-region and globally. Member of MAA Senior Leadership Team, Global Operational Excellence Leadership Forum, Global ISR Steering Committee
- M&D: VP/ Executive Directors- Development, Business Operations Planning and Administration
- Corporate: VP/Executive Director/Senior Director- Development, Communications, Events, Finance, Ethics and Compliance, Legal and Contracting
- External: Executive leadership of CROs, Production Companies and other Astellas partners
- BA/BS degree with at least 12 years of operations experience, with at least 5 years’ experience in developing regional operational strategies
- Strong knowledge of clinical operations, ICH/GCP guidelines and multi-national clinical trial regulations, including direct clinical trial and/or related experience
- 10+ years of people and/or matrix management experience; experience should include directing large budgets, strategic planning, operations management, resource planning and professional development