Specialty Medical Affairs Manager

4 weeks ago

Markham, Ontario, Canada Astellas Full time

Astellas Canada - Specialty Medical Affairs Manager

At Astellas, we are committed to being a leading, value-oriented innovator in the life sciences sector. Our mission involves being at the forefront of healthcare advancements to translate innovative science into tangible VALUE for patients.

What distinguishes us is our unwavering focus on patients, our groundbreaking innovations, our collaborative work environment, and the dedication of our skilled workforce.

Making a meaningful difference in patients' lives is the driving force behind all our endeavors. At Astellas, we are relentless in our quest for scientific advancement and in addressing unmet medical needs, as evidenced by our legacy in oncology, overactive bladder, and transplantation, alongside our robust pipeline in women's health, vision restoration, regenerative medicine, genetic regulation, immuno-oncology, mitochondrial health, and targeted protein degradation.

About Us:

We are a global pharmaceutical organization based in Japan, employing over 14,000 professionals across approximately 70 countries worldwide. We rank among the Top 30 global biopharma companies by revenue and are projected to be one of the Top 10 Cancer Drug Manufacturers in the near future.

In Canada, we are expanding to seize the exciting opportunities presented by our established brands and a rich pipeline of innovative therapies.

We seek candidates who will excel in our entrepreneurial and empowering culture where talent and leadership thrive. Do your values resonate with our Astellas Way - patient focus, ownership, results, openness, and integrity? We would be eager to connect with you.

From day one, every individual at Astellas plays a role in creating a brighter future for patients globally. We cultivate exceptional relationships with our employees to enable them to excel, foster innovation, and achieve outstanding business outcomes. We strive to build a culture where our people feel empowered to pursue bold ideas and ambitious goals, equipped with the confidence to be accountable for high performance and embody a competitive, solutions-oriented mindset.

Our expertise, scientific knowledge, and technological capabilities define us as a pharmaceutical company. Our inclusive and diverse culture is what makes us uniquely Astellas.

Astellas Pharma Canada is currently in search of a Medical Manager specializing in Women's Health, reporting to the Therapeutic Lead, Specialty. This position is based in the head office.

Role Overview

The Medical Manager is tasked with executing the medical strategy with a focus on Women's Health at the affiliate level. This involves coordinating and implementing medical and scientific initiatives to assess the local external landscape and identify data gaps, translating insights into actionable strategies, and ensuring that the information needs of key stakeholders are met to promote the safe and appropriate use of Astellas products.

Key Responsibilities

  • Provide strategic medical and scientific guidance to support all affiliate Medical Affairs initiatives and cross-functional collaborations.
  • Exhibit leadership by establishing and nurturing integrated partnerships with key internal and external stakeholders to ensure that all Medical Affairs activities align with local needs and enhance the medical/scientific understanding of Astellas products.
  • Engage with external stakeholders to advance the scientific understanding of compounds in development, as well as the safe and effective use of Astellas products and the diseases they address.
  • Collaborate with internal stakeholders, including brand teams, to achieve local business objectives.
  • Ensure that all Medical Affairs activities deliver value and are grounded in scientific validity, clinical relevance, and are executed on time and within budget.

Essential Functions

Understanding the External Landscape and Identifying Data Gaps

Scientific Intelligence

  • Demonstrate a comprehensive understanding of the therapeutic area, unmet needs, and emerging developments.
  • Engage with external stakeholders to gather and disseminate competitive scientific intelligence.
  • Develop and maintain in-depth scientific and medical expertise in the assigned therapeutic area.

Advisory Boards

  • Conduct advisory boards as necessary to solicit expert advice, opinions, and feedback on medical, humanistic, health economic, or clinical topics related to marketed or developmental compounds.

Medical Insights

  • Collaborate cross-functionally with internal teams to support the communication of relevant scientific and medical insights.
  • Oversee the generation of medical insights and integrate actionable findings into strategic planning processes.

Translating Insights into Strategies and Actions

Core Medical Plans

  • Identify unmet needs and formulate a medical strategy to be included in the Core Medical Plan.
  • Ensure compliant execution of all Medical Affairs activities at the affiliate level.

Collaboration Within M&D

  • Support the development team in identifying potential study investigators/sites.
  • Provide scientific and medical support to regulatory affairs for dossier submissions and presentations as needed.
  • Offer scientific and medical support to regional clinical operations and/or pharmacovigilance teams.
  • Partner with the Regional Operational Excellence team.

Collaboration with Commercial

  • Provide strategic scientific and medical expertise to Marketing, Market Access, Business Intelligence, and Sales teams.
  • Review and approve promotional materials.
  • Coordinate the execution of medical-scientific activities during product launches.
  • Participate as a therapeutic area/product expert in internal company meetings.
  • Deliver training on therapeutic areas and products to colleagues.

Meeting the Information Needs of External Stakeholders

Data Generation for HCPs and Payers

  • Collaborate with Health Economics and Outcomes Research and Market Access teams.
  • Plan and develop HEOR data generation projects.
  • Partner with market access teams during reimbursement discussions.

Data Communication and Medical Education

  • Provide medical and scientific education and training to internal stakeholders.
  • Act as the local scientific expert for the regional Medical Information group.
  • Strategically manage the development of local Non-Promotional Medical Materials.
  • Identify and engage key external experts for in-depth scientific exchange on medical products or disease areas.

External Program Funding for Research and Education

  • Assist the affiliate head in reviewing Investigator Sponsored Research/Grants.
  • Ensure post-activity evidence is obtained, including documentation and financial reconciliation.

Compliance & Governance

  • Ensure all Medical Affairs activities comply with applicable policies, external regulations, and ethical standards.
  • Collaborate with Ethics & Compliance to review promotional strategies and ensure adherence to compliance standards.

Field Medical Activities

  • Act as an office-based hybrid professional Medical Affairs leader responsible for identifying and effectively engaging with key external experts.

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