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 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:
The Associate Director, Health Economics & Outcomes Research (HEOR) is accountable for proactively formulating and implementing integrated Astellas strategies and tactics in response to emerging clinical and health economic trends and the changing healthcare landscape. This individual is accountable for providing HEOR expertise to and Core Medical Teams and Core Development Teams and ensures that HEOR perspectives are represented in the various plans (e.g. Core Medical Plan) for assigned compound(s). He/She is expected to have the knowledge and skills to design and execute a number of studies, economic models & other HEOR activities including but not limited to comparative effectiveness studies, observational studies using real world data, patient reported outcomes, and economic/cost-effectiveness modeling for in-line and development compounds. This position requires working closely with key external and internal stakeholders, including MA, Global & Regional Therapeutic Area colleagues, Global & Regional Pricing and Market Access, Global & Regional Affiliates and MA, Global/Asia Oceania/Japan/Americas HEOR colleagues to achieve business objectives. Specifically, this individual will:
* Execute health economic and outcomes projects that are medically relevant, scientifically valid and appropriately planned and executed
* Develop global HEOR tactics in alignment with key internal stakeholders that address data gaps at a product, corporate and industry-wide level
* Lead and execute projects with external stakeholders & HEOR experts to ensure that Astellas sponsored HEOR initiatives are clinically relevant and support the needs of regulators, patients, health care providers, payers and policy makers; and
* Develop and maintain product Core Value Dossiers (CVD) that will be utilized by region and country HEOR professionals to support local Health Technology Assessment (HTA) needs.
This position requires excellent interpersonal and matrix leadership skills to support effective partnerships with key internal and external stakeholders including TA colleagues, CMT colleagues, HEOR, Development, and Marketing Strategy (MS) colleagues.
Essential Job Responsibilities:
* Lead the global HEOR strategy for assigned products, including aligning and integrating Regional and Local Affiliate HEOR requirements
* Represent the aligned global HEOR position in the global teams (Global Value Team, Core Medical Team) and in the Medical Affairs governance committees (e.g. MA-C)
* Contribute to and lead a matrix team of a high performing HEOR experts that effectively implement an HEOR strategy that is integrated and aligned with CMPs/CDPs
* Provide HEOR expertise for HEOR projects/initiatives, protocol development, PRO development, regulatory documents, scientific publications, and independent research proposals for products/new indications in development, and oversee delivery of tactics according to timelines and budget for assigned products.
* Understand HTA requirements globally and provide TA and product based tactics that support HTA/Value data needs; ensuring implementation through inclusion in CMPs and CDPs
* Develop and maintain the medical/scientific sections of the Core Value Dossiers (CVDs) that provide the foundation for region and country HEOR professionals to create local Value Dossiers based on local HTA needs
* Actively monitor the changing healthcare landscape to anticipate future TA specific tactics
* Contribute to the maintenance of a global HEOR repository with a library of tools and instruments that support data generation and HTA needs
* Maintain full compliance with internal and external guidance and regulations, including applicable policies and codes
The Associate Director HEOR is directly responsible for data generation activities and related medical tools across one or more assigned products, support of HTA advice and submission needs (10+ countries annually) and management of multiple vendors as needed within their designated TA(s) for both development and in-line products. This includes indirect budget responsibilities of up to $1M.
The Associate Director, HEOR reports to the Senior Director, HEOR and will provide indirect matrix management of HEOR support within the assigned therapeutic area(s). He/She will have multiple cross-collaborative project teams and provide collaboration for the HEOR function globally of approximately 20 individuals within the assigned product teams.
The Associate Director will collaborate with the following colleagues:
* MA, Global Function: Medical Directors, HEOR leadership and TA counterparts
* MAA: Medical Directors; HEOR leadership (Senior Directors, Directors) and TA counterparts
* Regions: Medical Directors, HEOR leadership and TA counterparts
* Clinical Development: Senior Directors, Directors, HEOR counterparts
* Marketing Strategy, Global: Directors
* Commercial/Health Systems: Directors
* Other: Senior Directors/Directors Regulatory, Legal, Ethics and Compliance
* External: Leadership of Astellas partners and organizations
* Advanced degree (e.g. PharmD, PhD, MD, DO) with consideration for MPH or MSc + 7 years HEOR or epidemiology specific experience
* 3-5 years related experience in outcomes research including patient reported outcomes, health economics or epidemiology
* Experience in understanding interface between clinical practice and outcomes research
* Experience in leveraging outcomes data in the appropriate clinical context
* Solid understanding of various global HTA reimbursement and market access requirements and working understanding of industry and regulatory guidelines as they relate to HEOR and Medical Affairs
* Employs conceptual thinking and informational gathering to anticipate, identify, analyze and solve complex problems
* In-depth HEOR subject matter expert knowledge along with a broad knowledge of related disciplines (market access, clinical development, market research).
* Demonstrated strategic thinking and strong leadership skills
* Ability to synthesize and convey complex data or concepts in an understandable way.
* Ability to influence without formal authority
* Cultural sensitivity, ability to work in a global environment
* A collaborative style of working and a strong sense of ethics, compliance and integrity
* Persuasive and effective presentation style with strong written and verbal communication skills
* Demonstrated problem solving and decision-making skills
* Knowledge of various healthcare systems and solid understanding of related policy issues
* Demonstrated strong interpersonal relationship and collaboration skills working within cross-functional teams
* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 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
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
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