Associate Director, Global HEOR

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 may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

• Responsible for pro-actively formulating, consolidating, and implementing Astellas HEOR strategies and ensuring that HEOR perspectives and strategies across geographies are integrated within the MA core medical plans; integrated global value plans, evidence generation plans, brand plans; launch excellence plans and relevant development plans. Represents consolidated HEOR voice in cross-functional teams (e.g. GPST, CMT)

• Responsible for development, management and delivery of core health economic, comparative effectiveness, patient reported outcomes, and epidemiologic data, real world evidence, and budget impact and cost effectiveness analyses and modeling; for overseeing health technology assessment including early scientific advice and assessments post-approval for assigned inline and early (ESMA) and late-stage development compounds that are medically relevant and scientifically and technically valid, address business needs and support patient access and HTA/reimbursement requirements

• This position requires excellent interpersonal and matrix leadership skills to support effective partnerships with key internal and external stakeholders including global/regional/local HEOR leaders, Department Heads, TA Heads, CMT Leads, Development, Regulatory Affairs, and Market Access.

Essential Job Responsibilities:

Medical Affairs Leadership

• Co-lead development of integrated global value plan, co-create integrated global brand plan and integrated Evidence Generation Plan

• Responsible to develop HEOR strategies and tactics that are evidence based, scientifically and technically valid, and medically relevant; of clinical, humanistic, and economical importance; patient focused; are integrated in the Core Medical Plans and address the needs of regulators, HTA, payers, patients, health care providers, and policy makers and regulators across geographies and in line with global brand plan and global value plan, including strategy development for pre-POC early development compounds in ESMA

• Responsible for successful execution of all MA HEOR activities and deliverables for assigned product across geographies and to ensure these are delivered with high quality and within timelines and budget

• Accountable for the development and maintenance of core value dossiers and core economic models that provide the foundation for region and affiliate HEOR professionals to create local value dossiers and local economic models to fulfill local HTA/reimbursement needs across assigned products

• Leads PRO strategy development and early value assessment for ESMA

• Support regional / local adaptation of core value dossiers and core economic models to local HTA requirements and oversee alignment with the global value messages

Departmental and People Leadership

• Serve on organizational initiatives and taskforces as appropriate to shape the strategic direction of the HEOR function

Matrix Leadership

• Lead global value team and core health economics team

• Represents HEOR function in cross functional teams such as core team, GPST, CMT, ESMA team and ensures strategic needs and perspectives across geographies are represented

• Leads HEOR interaction with Development for ESMA products

• Maintains an integrated partnership within Medical Affairs and cross-functional colleagues including global Market Access to identify collaborative opportunities, ensure optimal alignment, leverage resources, and support business priorities

• Actively promote strategic collaborations with other Astellas HEOR colleagues across the globe to share and replicate best practices and advance HEOR initiatives to support the Astellas product portfolio and patient access.

Scientific / HEOR technical Expertise

• Maintains in depth knowledge of Astellas products/disease states for assigned products

• Provide strategic consultation to preparation and coordination for HTA/payer advice, mock preparations, submissions, face to face meetings and objection handling Actively monitor the changing healthcare landscape to identify emerging clinical and health economic trends

• Maintain in depth knowledge about patient access and HTA/reimbursement requirements, processes and best practices to inform HEOR strategies.

• Represent Astellas on HEOR issues at global forums, conferences and professional associations; including monitoring ad communicating activities by such forums to executive leadership

Medical Governance

• Provide oversight and strategic and scientific input for HEOR projects, data interpretation, protocol development, regulatory documents, scientific publications, and independent research proposals for assigned products

• Ensure the timely completion of assigned HEOR projects that include appropriate outcome assessments, analysis plans and final reports with expectations for peer-reviewed publications relevant to HEOR evidence generation strategies

• Ensures all HEOR deliverables support Astellas’ commitment to integrity and delivery of the highest standard of quality and in compliance with all applicable regulations, external policies and ethical standards

Quantitative Dimensions:

The HEOR Global Product Lead develops innovative, cutting edge economic, epidemiological and clinical outcomes data generation activities and related medical tools (>15 annually) across assigned products that are designed to shape the medical value proposition for Astellas products throughout their life cycle including early development compounds. The HEOR Global Product Lead will provide matrix leadership to represent regional and local HEOR within the GVT, CMT, GPST and iEGP teams. He/she is accountable for managing resources, priorities and workload across products and includes direct budget responsibilities of $1-1.5 mln annually. The results produced by the HEOR Global Product Lead must be scientifically sound and in compliance with applicable regulations

Organizational Context

The HEOR Global Product Lead reports to the Global HEOR TA Lead. They will have multiple

cross-functional collaborative project teams and matrix responsibility across the broader Astellas

organization.

The HEOR Global Product Lead will collaborate with the following colleagues:

• Medical Affairs: TA Heads, Executive Directors, CMT leads, ESMA leads, Senior Medical Directors/CMT members, HEOR Leaders

• Development: Global Development Project Leads, Core Team Leads, iEGP Leads, Core/Project Team members, Global Medical Leads

• Commercial and Market Access: Strategic Brand Managers/GSPT co-leads, Market Access Leads

• Other: Senior Director/Director Legal, Ethics & Compliance, Brand General Managers

• External: Executive leadership of Astellas partners and organizations

Qualifications

Required

• Advanced Degree (PharmD, PhD, MD) with consideration for MPH or other advanced degree in Life Sciences, HE or Epidemiology with relevant advanced industry experience

• 3-5 years relevant experience in at least one of the following fields: Outcomes Research, HE, Clinical Research, Epidemiology, Health Policy

• Demonstrated strategic thinking, problem solving and decision making skills

• Expertise in understanding interface between clinical practice and outcomes research

• Expertise in leveraging outcomes data in the appropriate clinical context

• Demonstrated strong interpersonal relationship and collaboration skills working within cross[1]functional teams

• Thorough understanding of global guidelines as they relate to HEOR and Medical Affairs

• Expertise in global HTA/payer reimbursement and market access requirements

• A collaborative style of working and a strong sense of ethics, compliance and integrity

• Excellent written and verbal communication and presentation skills

• Expertise in HEOR including principles, pharmaceutical research design and methods as well as excellent project and vendor management skills

Benefits

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Referral bonus program

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.

*LI-CH1

Category HEOR

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans