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Medical Affairs Global Strategic Brand Lead, Precision Medicine

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 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 Medical Affairs Global Strategic Brand Lead (MA GSBL) Precision Medicine (PM) is accountable for providing Medical Affairs strategic direction and support for CDx/Biomarker for relevant products both in Late Stages of Development and pre/post launch phases. This includes ensuring CDx strategies and tactics are represented in the Core Medical Plan (CMP) for the relevant product and remaining accountable for the delivery of the evidence generation and dissemination tactics. The MA GSBL PM ensures seamless execution of strategy and successful implementation of CDx tactics including:

+ Strategic oversight and support of evidence generation activities and other MA tactics related to the CDx/PM

+ Strategic alignment with the Commercial PM team to support the growth the PM business

+ Collaboration with key stakeholders in the co-creation countries to support CDx/diagnostic business and medical objectives.

+ Assessment of external medical environment, capture and communicate key insights to inform the global PM strategy

Essential Job Responsibilities:

Strategic Leadership:

+ Lead the development of Medical Product Strategy (MPS) ensuring CDx strategies and tactics are represented in the Core Medical Plan (CMP) for the relevant product

+ Contribute to creation of Integrated Evidence Generation Plan (iEGP) with cross-functional experts, serving as the strategic foundation for evidence generation

+ Define and oversee overarching objectives with medical KPIs, ensuring alignment with global and local Strategies

Medical Affairs Excellence:

+ Lead a high-impact team with accountability for delivery of CDx/PM evidence generation and dissemination tactics in the CMP for the relevant product, ensuring seamless execution that balances global objectives with local needs and adaptability. Accountable for budget management associated with evidence generation and dissemination tactics executed globally

+ Empower & enable affiliates to deliver on CDx/PM non-evidence generation and dissemination tactics of CMP for the relevant product, whilst encouraging iterative dialogue to address local needs

+ Ensure robust governance and review of synopsis/protocols of all CDx/PM MA sponsored studies maintaining high standards for evidence generation

+ Accountable for implementation of the Integrated Evidence Dissemination Plan with strong scientific messages to support CDx. Ensure provision of centralized resources and iterative feedback to refine scientific messaging

+ Enable the execution of the CDx/PM tactics of the Global launch plan for relevant product, providing KPIs and metrics to track global progress

+ Support internal and external medical education needs for CDx/Biomarkers in new disease areas/innovative treatment modalities with biomarker and CDx requirements

Cross-Functional Collaboration:

+ Foster cross-functional collaboration with Commercial, Market Access, Development, Patient Centricity, Local (co-creation) and Regional Medical Affairs teams to align on strategies and implement CDx/PM tactics for relevant products to address the needs of patients and healthcare providers

+ Partner with R&D teams to influence CDx/Biomarker development to streamline clinical viability and patient access at launch

+ Communicate key insights captured through advisory interactions and Field Medical, ensuring swift responses to evolving needs.

+ Drive integration and alignment across geographies, ensuring a consistent approach to medical affairs

+ execution and messaging concerning CDx/PM for the relevant product

Stakeholder Engagement:

+ Build and maintain strong relationships with external stakeholders, including diagnostic partners, testing labs, key external experts, advocacy groups, medical organizations and regulatory bodies, to strengthen the company’s global presence and reputation in PM

+ Act as a trusted representative for the company in external forums, conferences, and industry partnerships

Coaching and Team Development:

+ Coach and develop members of the team, fostering competencies and behaviors aligned with the Astellas way, CMT Ways of Working and preparing for future organizational needs

+ Drive cultural and operational transformation initiatives, ensuring long-term sustainable success

Compliance and Ethics:

+ Embed a strong compliance culture across all activities, ensuring adherence to company policies and industry regulations

+ Act as a role model for ethical behavior, fostering integrity and accountability within the organization

Qualifications Required:

Education:

+ A medical degree (MD or equivalent) or Doctorate degree in Pharmacy or Pharmacology recognized by one of the leading governing bodies from around the globe

Experience and Expertise:

+ Minimum 10+ years of progressive leadership experience in Pharmaceutical Medicine including 5 years in the CDx/PM space; preferably in Medical Affairs within the pharmaceutical industry/diagnostic company or alternatively in a commercial laboratory or academic institution.

+ Expertise in leading cross-functional and geographically diverse matrix teams while delivering high-impact business results. The ability to influence without direct authority is a critical skill set for this role.

+ Demonstrated success in leading the brand medical affairs strategy, including product launches and lifecycle management

+ Strong ability to develop innovative, patient-centered medical affairs evidence generation and dissemination strategies that drive patient access and brand performance

+ Strong understanding of industry trends, the regulatory environment, as well market access paths for CDx

+ Has advanced understanding of rules and regulations in pharma, including knowledge of global regulatory bodies and procedures, as well as anti-kickback laws, which could have impact for the pharmaceutical industry. Appropriate knowledge of guidelines and regulations such as IFPMA (International Federation of Pharmaceutical Manufacturers Association), PhRMA (Pharmaceutical Research and Manufacturers of America), FDA, EMA, PMDA, ACCME and OIG. Is able to apply legal and compliance knowledge to Medical Affairs activities

+ Experience in managing large budgets with demonstrated ability to apply proactive risk management on budget and timelines

Skills and Leadership:

+ Proven ability to lead and inspire high-performing global matrix teams in a fast-paced, matrixed environment

+ Exceptional strategic thinking, business acumen, and decision-making skills

+ Strong communication, influencing, and stakeholder management abilities

Preferred:

+ Medically qualified with at least 5 years of direct patient care

+ Work experience across multiple cultures and countries / regions.

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.

**Salary Range:** $263,000 - $350,000 (NOTE: Final salary could be more or less, based on experience)

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

Category MA Global Brand Strategy

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

EOE including Disability/Protected Veterans