Astellas Pharma Canada is currently searching for Head, TA Oncology MA – Canada in our Medical Affairs Division reporting to the Head MA - Canada.

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

Description:

Provides strategic Medical Affairs (MA) Leadership in overseeing all MA activities / deliverables for the assigned Therapeutic Areas (TAs). Demonstrates Matrix (local, regional, global) Leadership by developing and maintaining integrated partnership with stakeholders. Ensures all MA Deliverables address local business needs to bring value to patients and advance the medical/scientific understanding of Astellas products to help ensure safe and appropriate use across their lifecycle. Establishes and maintains collaborative partnerships with stakeholders, key external experts, and local and Global Astellas colleagues in order to optimise medical / scientific understanding and advocacy around Astellas medicines.

The Therapeutic Area Lead Oncology inspires others to excel by aligning people behind the Medical Affairs vision and motivating them to consistently commit to a standard of excellence and the achievement of superior results. He/she promotes a culture of compliance, innovation, constructive challenge, teamwork and accountability.

The Therapeutic Area Lead Oncology is an active member of the APCA

Medical Affairs Leadership Team (MALT)

Essential Job Duties:

• Utilizes a proactive approach to attracting, hiring, developing and retaining a high-performing TA MA department. Supports growth and development experiences that prepares the department for broader responsibilities and creates initiatives to ensure the retention of strong performers. Ensures that an appropriate and stretching Personal Development Plan is in place for all direct reports and provide timely, evidence based and constructive feedback. Ensures performance is regularly appraised, including conducting annual performance appraisal reviews. Provides coaching and timely feedback to ensure a productive, professional and motivated team and a highly valued work environment.

• Provides 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. Develops, implements, and manages 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. Provides medical / scientific perspective in development of strategic brand plans and other commercial initiatives as appropriate.

• Leverages medical / scientific expertise to support new product development efforts and success of locally marketed products. Identifies/anticipates information gaps and provides leadership in the timely development of medical / scientific communications

• which advance understanding of Astellas medications and promote product strategy.

• Provides medical / scientific leadership and coordination for clinical development in assigned therapeutic areas, as directed. Evaluates Astellas-sponsored clinical study opportunities and assesses investigator sponsored research (ISRs), based on scientific validity, clinical importance, fiscal feasibility and congruence with the strategic plan. Analyzes study data and effectively manages local study publication activities in a timely fashion.

• Leads and co-ordinates training of APCA personnel on medical/scientific information related to Astellas products within assigned TA (e.g. product/disease information, key publications).

• Develops and maintain relationships with Astellas Medical and Scientific Affairs colleagues and plays a significant role representing APCA in Regional and Global meetings.

• Cooperates with US, Established Markets and Global Medical Affairs in the design and/or implementation of international clinical studies in Canada. Provides a leadership role in implementing corporate plans for clinical trials in Canada.

• Establishes Medical / Scientific Affairs Advisory Boards and collaborates with advisors to strategize and implement Medical Affairs Strategic Plan.

• Develops and maintains collaborative partnerships with stakeholders, key external experts, and allied health professionals to ensure medical / scientific understanding and advocacy around Astellas medicines. Works with external stakeholders to ensure robust understanding of product use, evolving medical practice standards and health economic and outcomes research.

• Closely collaborates 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. Provides 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). Effective member of other Medical Affairs committees, including training, education, and publication committees.

• Embed Compliance Culture across all Regions of the business ensuring Integrity in Action is actively applied in all initiatives. Ensure Medical Affairs Function strictly adopt a culture of ethics and compliance; leading by example and appropriately challenging non-compliance. Ensure adherence to Astellas policies relating to Ethics and Compliance standards and interactions with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs) and Patient Organizations (POs).

• Provides significant input for development of departmental SOPs, guidance documents, and processes. Maintains awareness and expertise in political and regulatory influences affecting Medical Affairs activities.

• Provides medical / scientific expertise on safety and risk management issues including label review team (LRT), safety management meetings.

• Leverages medical / scientific expertise to support new product development efforts and commercial success of locally marketed products. Reviews new product licensing and acquisition opportunities for marketed and late-stage compounds.

Required Qualifications:

• A graduate degree in life sciences Ph.D / Pharm.D / MD

• Minimum 7 years pharmaceutical industry experience required (in Medical / Scientific Affairs, clinical research, project management).

• Knowledge of healthcare environment.

• Strong familiarity with biostatistical and health economics and outcomes research principles.

• Proven leadership ability.

• Excellent interpersonal, communication, presentation and administrative skills.

• Knowledge of local and international regulations, Innovative Medicines Code of Ethical Practices, and Good Clinical Practices (GCP)

• Strong analytic and problem-solving skills.

• Effective communication skills based upon balanced listening and evidence-based persuasion.

• Able to manage local, national, and international travel, with up to 30% overnight travel.

Preferred Qualifications:

• Assigned therapeutic area(s) experience.

• Bilingual (English/French)

If your skills and experience match our needs, please email your resume to: employment@astellas.com .

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.

Category Medical Affairs - Established Markets

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

EOE including Disability/Protected Veterans