Therapeutic Area Head, Oncology MA

4 weeks ago

Markham, Ontario, Canada Astellas Pharma Inc. Full time
Job Description

Astellas Pharma Canada is currently seeking a highly skilled and experienced professional to fill the role of Therapeutic Area Head, Oncology MA. This position is part of our Medical Affairs Division and will report to the Head MA - Canada.

This is a head office position located onsite in our Markham, Ontario.

Job Summary

The Therapeutic Area Head, Oncology MA will be responsible for providing strategic Medical Affairs leadership in overseeing all MA activities/deliverables for the assigned Therapeutic Areas (TAs). This includes developing and maintaining integrated partnerships with stakeholders, ensuring all MA deliverables address local business needs, and promoting a culture of compliance, innovation, and teamwork.

Key Responsibilities
  1. Provide strategic leadership and direction across all functions of the TA MA department to ensure all TA MA activities/deliverables are based on scientific validity, clinical importance, fiscal feasibility, and aligned to both the Core Medical Plans and local business needs.
  2. Develop, implement, and manage local integrated Medical Affairs strategic plan for assigned therapeutic areas, with specific input to definition of milestone dates and budgets in collaboration with Regional Core Medical Team and local cross-functional therapeutic teams.
  3. Leverage medical/scientific expertise to support new product development efforts and success of locally marketed products.
  4. Identify/anticipate information gaps and provide leadership in the timely development of medical/scientific communications which advance understanding of Astellas medications and promote product strategy.
  5. Provide medical/scientific leadership and coordination for clinical development in assigned therapeutic areas, as directed.
  6. Lead and coordinate training of APCA personnel on medical/scientific information related to Astellas products within assigned TA (e.g. product/disease information, key publications).
  7. Develop and maintain relationships with Astellas Medical and Scientific Affairs colleagues and play a significant role representing APCA in Regional and Global meetings.
  8. Cooperate with US, Established Markets and Global Medical Affairs in the design and/or implementation of international clinical studies in Canada.
  9. Establish Medical/Scientific Affairs Advisory Boards and collaborate with advisors to strategize and implement Medical Affairs Strategic Plan.
  10. Develop and maintain collaborative partnerships with stakeholders, key external experts, and allied health professionals to ensure medical/scientific understanding and advocacy around Astellas medicines.
  11. Closely collaborate with APCA Cross-functional Therapeutic team (including Sales, Marketing, Regulatory, Patient Access and Government Relations), as well with Medical Operations to support activities with marketed products and to meet corporate objectives.
  12. Provide medical/scientific expertise to launch planning teams including input in market research and target product profile, disease state management knowledge, draft labeling, planning for REMS/RMP's and other post-marketing initiatives, and expanded access programs (if applicable).
  13. Embed Compliance Culture across all Regions of the business ensuring Integrity in Action is actively applied in all initiatives.
  14. Ensure Medical Affairs Function strictly adopt a culture of ethics and compliance; leading by example and appropriately challenging non-compliance.
  15. Provide significant input for development of departmental SOPs, guidance documents, and processes.
  16. Maintain awareness and expertise in political and regulatory influences affecting Medical Affairs activities.
  17. Provide medical/scientific expertise on safety and risk management issues including label review team (LRT), safety management meetings.
  18. Leverage medical/scientific expertise to support new product development efforts and commercial success of locally marketed products.
Requirements
  1. A graduate degree in life sciences Ph.D/Pharm.D/MD.
  2. Minimum 7 years pharmaceutical industry experience required (in Medical/Scientific Affairs, clinical research, project management).
  3. Knowledge of healthcare environment.
  4. Strong familiarity with biostatistical and health economics and outcomes research principles.
  5. Proven leadership ability.
  6. Excellent interpersonal, communication, presentation, and administrative skills.
  7. Knowledge of local and international regulations, Innovative Medicines Code of Ethical Practices, and Good Clinical Practices (GCP).
  8. Strong analytic and problem-solving skills.
  9. Effective communication skills based upon balanced listening and evidence-based persuasion.
  10. Able to manage local, national, and international travel, with up to 30% overnight travel.

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.

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

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