Medical Manager, Specialties

Astellas Canada - Medical Manager (Medical Affairs), Specialties - Markham, Ontario - CANADA, Hybrid role

The Medical Manager is responsible for the implementation of the medical strategy (Core Medical Plan, “CMP”) with a focus in Women’s Health at the affiliate level by coordinating and executing medical / scientific activities.

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

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.

RESPONSIBILITIES

(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.

• Provide strategic medical and scientific expertise in support of all affiliate Medical Affairs (MA) deliverables and cross-functional activities
• Demonstrate 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 science behind compounds in development, the safe and effective use of Astellas products and disease states that they treat.
• Responsible for engaging and collaborating with key internal stakeholders, including the brand teams across the affiliate to achieve local business objectives
• Ensures all affiliate MA activities deliver value and are based on scientific validity, clinical importance and on time and budget.

Essential Job Duties, Scientific Intelligence

• Demonstrate thorough understanding of the therapeutic area (TA), 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 TA through self-study, company-provided training and scientific meeting attendance

Advisory Boards

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

Medical Insights

• Collaborates cross functionally with internal stakeholders to support communication of relevant scientific and medical insights
• Oversee medical insights generation activities and incorporate actionable insights into the 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 medical strategy to incorporate in the CMP as well ensure a compliant execution of all Affiliate Medical/Scientific activities 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, and local brand strategies
• Strategically leverage regional and 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
• 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,
• 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 to Marketing, Market Access, Business Intelligence, Sales in support of all cross-functional activities (advice, reports, recommendations, etc.).
• Champion a collaborative mindset to ensure full alignment with key stakeholders’ cross-functionally
• Review and approve promotional materials complying with local and applicable internal/external regulations and/or policies.
• Coordinate in executing medical-scientific activities in product launches: disease area presentations, expert meetings.
• Participating as a therapeutic area/product expert in internal company meetings and provide medical-scientific support for external meetings in a fair and balanced manner (post-approval symposia)
• Provide training on therapeutic area and products to the colleagues (including commercial) in the affiliate

Fulfill Information Needs of External Stakeholders, Data Generation for HCPs and Payers

• Partner 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 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 experts (KEEs) in in-depth medical product or disease area 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 and local regulations
• Develop, maintain, engage with (KEEs), HCPs, healthcare organizations funding bodies and other entities 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 documentation and financial reconciliation

Compliance & Governance

• Ensures all affiliate MA 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 Medical Affairs leader responsible for identifying, accessing and effectively engaging with key external experts to foster scientific exchange and mutually beneficial collaboration.

Required Qualifications

• Doctoral degree (MD, PhD in health-related science or PharmD)
• Minimum 4 years’ experience in Pharma.
• 3-5 years’ experience in Medical Affairs
• Suitable candidates from academia 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.
• Strong understanding and knowledge of industry laws and regulations.
• Experienced in managing complex projects and effectively act independently (ex. Ad Boards, Publications).
• Demonstration & ability to effectively interact in matrix organization with matrix reporting lines.
• Proactive strategic partnering with different internal functions (ex. Commercial, Market Access, HEOR.)
• Excellent presentation skills and advanced written and verbal business English.
• Foundational understanding of the drug development and commercialization process. Ability to travel 20-30% of the time including overnight travel

Preferred Qualifications

• ​Contributing to / supporting onboarding and development activities for colleagues e.g., acting as a buddy, mentor or coach
• ​Demonstration of delegated responsibilities successfully completed e.g., acting as a backup for a Therapy Area Lead at key internal or external meetings.

Astellas Pharma Canada welcomes, 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.