About the role
Our client, an international and fast-growing pharmaceutical company, is looking for a Medical Director for its newly established Canadian affiliate. You will be a core member of team the Canadian leadership, overseeing all medical, scientific and regulatory affairs activities for the affiliate.
This is a founding leadership role with the opportunity to build and lead the medical, scientific, regulatory, and pharmacovigilance functions from the ground up. You will combine strategic vision with hands-on execution, ensuring scientific excellence, regulatory compliance, and medical insights that drive business success.
This role combines strategic leadership and hands-on execution: you will shape the Canadian medical affairs strategy, ensure scientific and regulatory compliance, engage with key opinion leaders, and provide cross-functional medical expertise to support product launches and growth initiatives. This role reports directly to the Managing Director.
What you'll do
Medical Strategy & Regulatory Affairs Leadership
- Develop and implement the medical affairs strategy for the Canadian affiliate in alignment with global objectives and local needs.
- Serve as a trusted medical advisor to the General Manager and leadership team, ensuring decisions are grounded in robust scientific and clinical insights.
- Build and lead the Canadian medical team (including MSLs), fostering a collaborative, high-performing culture.
- Provide strategic leadership and oversight to the Regulatory Affairs team, ensuring alignment with medical and corporate objectives.
- Oversee regulatory strategy development and execution, ensuring compliance with global health authority requirements.
- Oversee all QA, MI/PV partnerships in close collaboration with global teams.
- Establish governance frameworks, SOPs, and inspection-ready compliance infrastructure.
Stakeholder Engagement
- Establish and maintain strong relationships with key opinion leaders (KOLs), investigators, and relevant professional associations.
- Act as the primary medical point of contact for external stakeholders, including healthcare providers, industry associations, and scientific partners.
- Represent the company at advisory boards, congresses, and medical/scientific events.
Cross-functional Support
- Partner with Commercial, Market Access, and lead the Regulatory Affairs team to ensure the medical perspective informs business strategies and market access plans.
- Provide medical review and approval of Canadian promotional materials, scientific communications, and training content in compliance with PAAB and other relevant standards.
- Offer medical expertise for Health Economics & Outcomes Research (HEOR) initiatives, patient access programs, and pricing strategies.
Clinical & Regulatory Collaboration
- Support local clinical trial feasibility, investigator selection, and execution in collaboration with global R&D and clinical teams.
- Provide medical input for regulatory submissions and interactions with Health Canada, in collaboration with the regulatory function.
- Oversee pharmacovigilance activities at the affiliate level and ensure compliance with safety reporting obligations.
What we're looking for
Education & Experience
- MD, PharmD, or PhD in a life sciences discipline .
- 10+ years of progressive medical affairs and/or clinical development experience in the pharmaceutical or biotech industry, with at least5 years in a leadership role.
- Previous experience supporting product launches in specialty care is a strong asset.
- Demonstrated expertise in medical governance and compliance with Canadian regulations (PAAB, Health Canada).
- Strong understanding of global regulatory requirements, submission processes, and health authority interactions (e.g. Health Canada)
Skills & Attributes
- Entrepreneurial mindset with the ability to build medical functions from the ground up.
- Strong network-building skills and proven success engaging KOLs and scientific experts.
- Excellent communication and presentation skills, capable of influencing diverse stakeholders.
- Collaborative, hands-on leader with the ability to thrive in a fast-paced, start-up affiliate environment.
Languages
- English fluency required; French is an asset.
Why Join?
At our client’s organization, you’ll join a people-driven, collaborative organization that values innovation, integrity, and quality. As part of the founding leadership team in Canada, you’ll have the rare opportunity to shape the medical function of a growing affiliate while contributing to a global mission: improving patient lives through innovative treatments for blood diseases and beyond.