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.

Description

The Global Medical Affairs Lead will be globally responsible for Medical Affairs (MA) activities for assigned products in late-stage development, post-launch, and for life cycle management (when required). This position will support MA Global Strategic Brand Lead (MA GSBL) facilitating collaboration across a matrix organization to ensure the creation and execution of the Core Medical Plan (CMP) and integrated evidence generation plan (iEGP). The CMP includes MA sponsored data generation (including Health Economics and Outcomes Research (HEOR)) that addresses existing and future data gaps and supports reimbursement needs. The Global MA Lead is responsible for identification of the information needs of external stakeholders such as data generation for HCPs and Payers, data communication and medical education. The position also supports routine and ad-hoc assessments of the Benefit/Risk of assigned products.

When required the Global MA Lead shall represent the MA GSBL at Astellas senior leadership meetings (e.g. Global Benefit Risk Committee (GBRC), Medical Affairs Leadership Team (MALT. The Global MA Lead shall be expected to closely collaborate with GCT, leading to the creation and execution of an integrated Global Brand plan (iGBP). Collaboration with Development will support clinical development programs for new indications or line extensions for marketed products.

Essential Job Duties

Support MA GSBL in the development of the Core Medical Plan for assigned product(s) and timely execution.

Support the creation and delivery of centralized medical content for medical education, scientific exchange and internal and external training

Provide Medical input into creation of global commercial content for local use

Partner with HEOR lead to drive HEOR gap analyses and ensure projects to address these gaps are reflected in the CMP and support the creation of the Core Value Dossiers and outer outputs needed to support Access.

Provide support in coordinating medical activities at medical and scientific conferences.

Contribute to discussions with Development colleagues and ensure that MA (including HEOR) perspectives are provided and incorporated in Development plans.

Builds effective communication channels between global and region/co-creation affiliates

Build and maintains relationships with global experts and able to obtain important key scientific insights to support the TA.

Collaborates and supports creation and the execution of the publication plan

Has a solid understanding of the regulatory and reimbursement environment and contributes to regulatory and reimbursement strategies for the product

Effectively works within matrix teams of global and functional colleagues; ensure effective cross- regional and cross-functional collaboration; in collaboration with MA GSBL aligns all

key MA projects globally for assigned product and indication.

In close collaboration with MA GSBL, represents/leads MA during iGBP creation and all launch readiness related activities where appropriate.

As required fulfil the responsibility for MA SPoC for benefit-risk assessments for some Astellas Global products

Fosters competencies and behaviors aligned with the Astellas way, CMT Ways of

Working and preparing for future organizational needs

Supports execution of CMP within budget and within timelines.

Required Qualifications

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

At least 5 years total industry experience including country/region or global medical affairs, medical safety or clinical development. At least 3 years Medical Affairs

Has knowledge of TA/disease/product and is able to operate across several products

within TA.

Demonstrated success in leading the brand medical affairs strategy, including product launches

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

Has knowledge of TA/disease/product and is able to operate across multiple products within TA.

Has a good 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.

Fluent in written and verbal business English.

Skills and Leadership:

Good strategic thinking, business acumen, and decision-making skills

Strong communication, influencing, and stakeholder management abilities

Complex problem-solving skills

Preferred Qualifications

Medically qualified with at least 3-5 years of direct patient care

Medical specialty and/or experience in relevant therapeutic area.

Work experience across multiple cultures and countries / regions.

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.

Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.

No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted.

Category MA Global Brand Strategy

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

EOE including Disability/Protected Veterans