Medical Specialist, MA-US

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:

The Medical Specialist, Oncology MA-US (Medical Affairs-United States) is responsible for the implementation of the medical strategy (Core Medical Plan) in the designated therapeutic area at the affiliate level by coordinating and executing medical / scientific activities to (i) understand the local external environment and data gaps; (ii) translate insights into strategies and activities and (iii) ensure the information needs of key stakeholders are fulfilled to help ensure the safe and appropriate use of Astellas products.

The Medical Specialist, Oncology MA-US specifically will:

• Provide strategic medical and scientific expertise in support of all affiliate’s Medical Affairs deliverables and cross-functional activities.

• Demonstrate matrix leadership by developing and maintaining integrated partnerships with key internal and external stakeholders to ensure all MA affiliate activities address local needs and advance the medical/scientific understanding of Astellas products across their lifecycle.

• Responsible for understanding and engage external stakeholders to advance the understanding of and science behind compounds in development, the safe and effective use of Astellas products and disease states that they treat.

• Responsible for engaging and working closely with key internal stakeholders, including the brand teams across the affiliate to achieve business objectives for the affiliate.

• Ensures all affiliate MA activities deliver value and are based on scientific validity, clinical importance and on time & budget.

• Responsible for the Medical component of reviewing and approving promotional materials complying with local.

• The exact % of each area of focus and delivery for this role will vary depending on business needs and experience level. For some individuals in the role, 80% or greater of their time will be spent on MAP (Material Approval Process).

Essential Job Responsibilities:

Understand External Environment and Data Gaps:

Scientific Intelligence

• Demonstrate thorough understanding of the therapeutic area, its current status, unmet needs and future developments.

• Engage external stakeholders (such as health care providers, payers, and decision makers) and gather as well as share competitive scientific intelligence.

• Develop and maintain in depth scientific and medical expertise of assigned therapeutic area through self-study, company-provided training and scientific meeting attendance in order to enhance the contribution to the company.

Advisory Boards

• Conduct advisory boards as needed per the life cycle of the product to seek expert advice, opinions and feedback from advisors and other stakeholders on medical, humanistic, health economic or clinical topics related to marketed products or development-stage compounds to inform medical affairs and commercial strategies, plans.

Medical Insights

• Collaborates cross functionally with internal stakeholders to support communication of relevant scientific and medical insights to internal stakeholders.

• Oversee medical insights generation activities and ensure actionable insights are incorporated in strategic planning processes in collaboration with operational excellence and regional TA leads.

Translate Insights into Strategies and Activities:

Core Medical Plans

• Identify the unmet needs and develop suitable medical strategy to incorporate in the CMP as well ensure a compliant execution of all Affiliate Medical/Scientific activities (including vendor oversight) i.e. launch activities, educational programs, advisory / expert meetings, symposia in congresses.

• Ensure the affiliate CMP is aligned with Global CMP, Integrated global brand plan, as well as local brand strategies.

• Strategically leverage regional and/or global medical initiatives to meet local business needs, while maintaining an enterprise view.

• Implement the affiliate CMP tactics for the TA, on time and on budget as well as update CMP trackers on time.

Collaboration Within M&D

• Provide reactive support to development team to identify potential study investigators / sites and assist with feasibility study execution for registration studies.

• Provide scientific/medical support to regulatory affairs on submission of dossiers and presentations upon request.

• Provide scientific/medical support to regional clinical operations and/or pharmacovigilance teams in execution of mandatory post-approval studies as needed.

• Partner with Regional Operational Excellence team to provide regular input to monthly reports for the General Manager/Regional President/Chief Medical Officer

Collaboration with Commercial

• Provide strategic scientific/medical expertise in support of all cross-functional activities (Marketing, Market Access, Business Intelligence, Sales).

• Champion a collaborative mindset to ensure full alignment with key stakeholders cross-functionally.

• Review and approve promotional materials complying with local and applicable nternal/external regulations and/or policies.

• Provide scientific /medical support to Marketing, Market Access, Business Intelligence (advice, reports, recommendations, etc.).

• Coordinate in executing medical-scientific activities in product launches: disease area presentations, expert meetings.

• Participating as a therapeutic area/product expert in internal meetings of the company and provide medicalscientific support for external meetings in a fair and balanced manner (post-approval symposia).

• Provide consistent training on therapeutic area and products to the colleagues (including commercial) in the affiliate.

Fulfil Information Needs of External Stakeholders

• Data Generation for HCPs and Payers

• Partner closely with the Health Economics and Outcomes Research (HEOR) and Market Access to provide insight on local access strategies and challenges and close data gaps.

• Plan and develop HEOR data generation projects, not limited to Budget Impact Model/ Cost-effectiveness analysis.

• Partner with market access in reimbursement or listing discussions with payers/hospitals as needed.

Data Communication and Medical Education

• Provide medical / scientific education and training to internal stakeholders on marketed products and compounds in development.

• Acts as local scientific/medical expert to regional Medical Information group (i.e. escalated inquiries), ensuring all local regulatory requirements are met and in compliance with Astellas procedures and ethical standards.

• Strategically manage the development of local Non-Promotional Medical Materials in alignment with TA/ affiliate objectives, including, but not limited to slide presentations and posters / manuscripts.

• Identify and engage key external customers (KEEs) in in-depth medical and scientific product or disease area discussions / scientific exchange, and presentations to communicate the value of Astellas products in a fair and balanced way in accordance with Astellas values/code of conduct as well as applicable local regulations.

• Develop, maintain, engage with key external experts (KEEs), healthcare professionals, healthcare organizations funding bodies and other entities to engage and communicate the value of Astellas products in a fair and balanced way accordance with Astellas values/code of conduct as well as applicable local regulations.

External Program Funding for Research and Education

• Support the affiliate head and regional reviewers in reviewing as well as appropriate documentation of Investigator Sponsored Research/ Grants for general research/ Grants for Medical Education/ Sponsorship for Research & Education.

• Obtain post-activity evidence, including financial reconciliation documents to confirm that the provided grant support was utilized according to the executed legal agreement, and this is documented in the applicable system.

Compliance & Governance

• Ensures all affiliate medical affairs activities are in compliance with all applicable Astellas policies, external regulations and ethical standards.

• Partners with Ethics & Compliance to review commercial led promotional tactics and inputs to ensure adherence to compliance in all areas of operations.

Field Medical Activities

• An office-based hybrid professional with scientific and therapeutic-area expertise in disease state management, brands, emerging therapies, and the competitive landscape.

• Responsible for identifying accessing and effectively engaging with 15-20 (depending on the size of the country and affiliate business) active and potential KEEs aligned with the respective therapeutic area strategies that foster scientific exchange and collaboration.

• The Medical Specialist, Oncology MA-US provides MA support for one product within the TA including accountability for the tasks assigned. The Medical Specialist, Oncology MA-US is part of a high performing medical team with direct responsibility of tactics including review of over 50 promotional material and working on up to approximately 10 medical tools annually. The results produced by the Medical Specialist, Oncology MA-US must be scientifically sound and in compliance with applicable regulations.

Qualifications Required:

• Doctoral degree (MD, PhD in health-related science or PharmD).

• 3-5 years in Medical Affairs or clinical experience.

• Suitable candidates from academia or clinical practice with Strong expertise in the therapeutic area including clinical/ hospital practice, clinical development, experience in designing, executing, and reporting of clinical trials can be considered.

• Understanding of the drug development process as well as commercialization.

• Preferable a good understanding of the dynamics of a large corporate environment.

• Comfortable with matrix reporting lines.

• Knowledge and strong understanding of and ability to comply with industry laws and regulations.

• Experienced in managing complex projects independently (such as but not limited to Advisory Boards, Publications, Preceptorship, etc...)

• Proactive strategic partnering with different internal functions.

• Developed presentation skills confirmed by the audience.

• Excellent presentation skills; fully fluent in written and verbal business English.

Working Environment:

• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Benefits:

• 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

Category Medical Affairs - USA

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

EOE including Disability/Protected Veterans