Our client is currently searching for a Medical Manager reporting to the Therapeutic Lead, Oncology. This is head office position located in Markham, Ontario.
The Medical Manager is responsible for the implementation of the medical strategy (Core Medical Plan) in the designated therapeutic area at the affiliate level by coordinating and executing medical / scientific activities to understand the local external environment and data gaps, translate insights into strategies and activities, and ensure the information needs of key stakeholders are fulfilled to help ensure the safe and appropriate use products.
Specifically, this individual will:
- In collaboration with the TA lead Provide strategic medical and scientific expertise in support of affiliate Medical Affairs TA deliverables and cross-functional activities
- Demonstrate matrix leadership by developing and maintaining integrated partnerships with internal stakeholders to ensure TA specific MA affiliate activities address local needs and advance the medical/scientific understanding of products across their lifecycle
- Understand, align, and engage with external stakeholders to advance the understanding of and science behind compounds in development, the safe and effective use of Astellas products and disease states that they treat Ensures affiliate MA activities deliver value and are based on scientific validity, clinical importance and fiscal feasibility.
- Demonstrate thorough understanding of the therapeutic area, it’s current status, unmet needs and future developments
- Engage external stakeholders (such as health care providers and decision makers) and gather as well as share competitive scientific intelligence
- Develop and maintain in depth scientific and medical expertise of assigned therapeutic area through self-study, company-provided training and scientific meeting attendance in order to enhance the contribution to the company
- In collaboration with the TA lead conduct advisory boards as needed per the life cycle of the product to seek expert advice, opinions and feedback from advisors and other stakeholders on medical, humanistic, health economic or clinical topics related to marketed products or development-stage
- Collaborate cross functionally with internal stakeholders to support the communication of relevant scientific and medical insights
- Support medical insights generation activities and ensure actionable insights are incorporated in strategic planning processes in collaboration with operational excellence and local and regional TA leads
- Identify the unmet needs and support the development of suitable medical strategy to incorporate in the CMP as well work closely with the TA lead to ensure a compliant execution of all Affiliate Medical/Scientific activities (including vendor oversight) i.e. launch activities, educational programs, advisory / expert meetings, congresses
- Strategically leverage regional and/or global medical initiatives to meet local business needs, while maintaining an enterprise view
- Understand and meet needs of product lifecycle management through resource deployment planning meeting stakeholder engagement strategies
- Implement the affiliate CMP tactics for the TA, on time and on budget as well as update CMP trackers on time
- When required Partner with Development team to identify potential study investigators / sites and assist with feasibility of 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 as needed.
- Partner with Regional Operational Excellence team to provide regular input to monthly reports for the General Manager/Regional President/Chief Medical Officer
- Champion a collaborative mindset to ensure full alignment with key stakeholders cross-functionally
- Provide strategic scientific/medical expertise in support of all cross-functional activities (Marketing, Market Access, Business Intelligence, Sales)
- Review and approve promotional materials, complying with local and applicable internal regulations and/or policies.
- Partner closely with the Health Economics and Outcomes Research (HEOR) and Market Access to provide insight on local Access strategies and challenges and close data gaps
- Provide medical / scientific education and training to internal stakeholders on marketed products and compounds in development
- Act as local scientific/medical 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 objectives, including, but not limited to slide presentations and posters / manuscripts
- When required engage HCPs in in-depth medical and scientific product or disease area discussions / scientific exchange, and presentations in a nonpromotional scientific manner to communicate the value of Astellas products in a fair and balanced way in accordance with Astellas values/code of conduct as well as applicable local regulations
- Support the TA lead 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 financial reconciliation documents to confirm that the provided grant support was utilized according to the executed legal agreement and this is documented in the applicable system
- Ensures all affiliate medical affairs activities are in compliance with all applicable policies, external regulations and ethical standards Maintain up-to-date knowledge of Regulatory guidelines, Code of Practices and Company SOPs to ensure adherence and be a role model in the organization.
- Maintain up-to-date knowledge of local regulatory guidelines, and Company SOPs and recognize situations that require legal/compliance input and seek guidance as appropriate to ensure adherence to compliance in all areas of operations.
- Manages expectations of both internal and external stakeholders regarding what Medical Affairs can and cannot do based on solid understanding of company, regulatory and legal boundaries by maintaining up-to-date knowledge of Regulatory guidelines, local country Code of Practice and Company SOPs to ensure adherence in all areas as appropriate.
- Doctoral degree (MD, PhD in health related science or PharmD)
- At least 3-5 years’ experience in Pharma, particularly in Medical Affairs.
- Strong expertise in the medical sciences, clinical development, medical program design including experience
- Understanding of the drug development process as well as commercialization
- A good understanding of the dynamics of a large corporate environment; comfortable with matrix reporting lines.
- Knowledge and strong understanding of and ability to comply with industry laws and regulations.
- Excellent presentation skills; fully fluent in written and verbal business English.
- Oncology Experience and Bilingualism (French/English) is preferred
Note that all applications are welcome, but only successful applicants will be contacted.