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:

The Medical Lead, MA-US is accountable for supporting the implementation and execution of medical and scientific strategies for one or more product within the therapeutic area (TA) or for TA activities that cover the entire TA.

The Medical Lead, MA-US is responsible for:

• development of overall scientific and medical strategy for assigned product(s)

• creation and management of internal product/TA strategy and training

• strategic oversight and execution of data generation activities and other MAUS tactics

• review and endorsement of, and in some cases creation of scientific exchange materials, product launch

planning/operations, and strategic congress planning, including collection and assessment of external

medical insights to shape medical strategies

• collaboration with key stakeholders across the company to support business objectives for the US Region, if applicable, and ensuring alignment with and support of Medical Affairs (MA) colleagues within the region

• assessment of external medical environment perspectives and informing of medical strategies, including global strategies.

Essential Job Responsibilities:

• Help with development and execution of solid strategic medical plans for the assigned products within the TA that are aligned with the global Core Medical Plan (CMP)

• Accountable for oversight and execution of MA-sponsored clinical studies, as applicable

• Drive scientific and medical development and approval of sound study synopsis, protocols and study reports, including health economic & outcomes research (HEOR) related studies, ensuring clinical and scientific accuracy

• Align with peer leaders in the Commercial organization and cross-functional teams, providing strategic medical direction to support the needs of the business

• Demonstrate ability to collaborate and lead within matrix product/TA teams across multiple disciplines

• Represent MAUS on the relevant CMT, including representation of all regional needs and activities and timely execution of the CMP tactics

• Provide medical expertise and approval of promotional materials

• Provide medical expertise and approval of non-promotional medical materials, including but not limited to slide presentations, local dossiers, health outcomes models, etc.

• Review and approve all standard and custom Medical Information response letters

• Initiate and support medical advisory boards within area of responsibility to understand and shape medical strategies

• Partner with medical science liaison (MSL) team in the field, effectively translating insights into regional and global strategy

• Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable

• Lead scientific review of investigator sponsored research (ISR) proposals in the TA; may chair Regional ISR Committee if applicable

• Provide medical expertise related to new product licensing and acquisition opportunities for the US

• Foster a culture of 100% compliance and embody One Astellas and the Astellas Way

Qualifications

Required

• Medical Degree (MD or DO)

• Minimum 3 years clinical or academic experience after residency training

• Experience in the US

• Experience in working in matrix organization collaborating with medical, clinical, regulatory, health economic & outcome research, epidemiology, medical information, commercial and other organizational partners to deliver results

• Solid scientific analytical and problem-solving skills, strategic capabilities, project management and planning and organizational skills

• Ability to communicate effectively, including scientific concepts, both in writing and in oral presentations

• Ability to design and conduct various phases of clinical trials, including ability to critically review and analyze study designs

• Ability to collaborate within matrix structured product team across multiple disciplines

• Ability to effectively engage both internal and external stakeholders, customers and collaboration partners.

• Demonstrated ability to collaborate and build strategic alignment within the Medical Affairs community and across functions (e.g., Commercial).

• Fluent in written and verbal English

• Approximately 20% travel required

Preferred

Minimum 2 years Medical Affairs relevant experience within the pharmaceutical industry

• Medically Qualified with post graduate qualification and specialization in appropriate therapeutic specialty preferred

• Board Certified in relevant therapeutic area

• Active medical license

• Experience in medical research

• Extensive knowledge of US healthcare delivery systems (e.g. accountable care, managed care, pharmacy benefit management, government [Medicare, Medicaid]) and solid understanding of policy issues)

• Demonstrated strong interpersonal relationship and collaboration skills working within cross- functional executive leadership teams

• Thorough understanding of FDA/PhRMA, OIG, Health Canada/Innovative Medicines Canada,

• ANVISA/ANS and other guidelines as they relate to HEOR and Medical Affairs

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.

• Travel will be required around 20% of time.

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-TD

Category Medical Affairs - USA

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

EOE including Disability/Protected Veterans