Job Description

Medical Affairs Global Strategic Brand Lead, Precision Medicine

At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.

What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.

Making a positive impact on patients' lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.

About Us:

We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.

In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.

We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.


From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.

Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.

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

+ This position is remote and is based in CanadaAt 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.

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Additional Information

Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.

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