Sr Director, Medical Affairs - Canada

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

The Senior Director of Medical Affairs is tasked with providing both strategic and operational leadership for the Medical Affairs function in Canada, supporting both marketed and pipeline products. This role involves creating, building, and executing strategies that are aligned with global and Americas medical affairs initiatives, ensuring these strategies are effectively adapted to the local and regional context.
As a member of the Americas Medical Leadership team, the Senior Director thrives in a collaborative, diverse, and fast-paced environment to deliver transformative therapies for individuals with rare diseases. Reporting to the Vice President of Medical Affairs for the Americas, this position works closely with medical leaders from the US and LATAM. Although leading the Canadian division, the Senior Director must maintain a broad vision, understanding that decisions made within the Americas can have regional or global implications. As a senior leader, this individual is expected to contribute innovative ideas and solutions to challenges faced by the sub-regions.
This role involves managing scientific and clinical content for ongoing or new projects in close collaboration with the Americas/Global medical affairs teams, the Country Manager for Canada, and heads of Marketing and Market Access, among other relevant PTC functions. The aim is to position the Canadian region for successful product launches and growth in the rare disease sector. The Senior Director will also interface with General Managers in the Americas and North America, ensuring the Canadian strategy aligns with the broader goals of these positions.
The incumbent should possess a robust scientific background and the ability to comprehend and convey complex scientific data. This includes forming lasting medical and scientific partnerships with healthcare professionals by demonstrating comprehensive knowledge across multiple therapeutic areas, providing scientific and medical advice, and communicating medical evidence to healthcare professionals. As the clinical and medical expert on PTC's products, the Senior Director is responsible for fostering long-term relationships and building rapport with clinicians in hospitals, clinics, and academic centers through in-depth scientific discussions regarding products and disease states, thereby supporting or expanding current therapeutic concepts and ensuring the safe and effective use of products.
Additionally, the Senior Director is accountable for delivering scientific publications, presentations, educational programs, and clinical data generation, as well as the design and management of other medical affairs deliverables across Canada and the Americas region, as needed.
The Sr Director, Medical Affairs – Canada, coaches and mentors’ direct reports.
The Sr Director, Medical Affairs ensures adherence to relevant regulatory requirements and company Standard Operating Procedures {SOPs) as appropriate.

Job Description:

Responsibilities:

• Creates and implements country medical affairs strategy, influences global and regional strategic plans.
• Drives the tactical implementation of medical affairs plans across the country, including but not limited to: KOL development and relationship building as well as the building of the scientific communications platform (publications, congresses etc.) and other related projects.
• Ensures execution of medical affairs strategy and builds and maintains trusted medical/scientific relationships with health community stakeholders.
• Interacts with local authorities, local Key Opinion Leaders (KOLs) and payors, patient organizations as well as other external stakeholders.
• Collaborates and works closely with Americas Medical Leadership team bringing medical insights, best practices and supporting the regional business operations and will be a member of Americas Medical Affairs Leadership,
• Collaborates and works in alignment with Country Manager on all aspects of medical business operations and will be a member of the North American Leadership Team,
• Collaborates with Marketing/Commercial / Market Access to ensure that the local strategic medical affairs plans are in line with the marketing plan/brand strategies.
• Collaborates with Americas and Global training teams to provide training and scientific education to commercial, medical teams and other internal stakeholders.
• Provides medical guidance, support and input working with market access teams for new products.
• Acts as the final signatory in the review and approval of promotional and non-promotional materials regarding medical accuracy and compliance to local regulation and code of practice.
• Manages and directs medical information processes and services in close collaboration with other functions in medical affairs.
• Identifies and fosters trusted relationships with local thought leaders, engages in scientific exchange and develops rapport with experts in the therapeutic area. Identifies, organizes, and carries out regional medical initiatives (i.e., leads medical discussions at national or regional advisory board meetings).
• Leads and supports the MSL team to identify local thought leaders, engages in scientific exchange and develops rapport with experts in the therapeutic area. Support the MSL team to organize and carry out regional medical initiatives (i.e. leads medical discussions at national advisory board meetings).
• Manages direct requests for compassionate use of PTC medicines as appropriate for patients in Canada in collaboration with their managing clinician and PTC ACTS.
• Provides support in the administration of clinical trials on request by Clinical Development teams; collaborates and provides support to other departments, especially to Regulatory Affairs and Pharmacovigilance (PV); represents Global Medical Affairs at local, regional and international scientific congresses.
• Manages, coaches and mentors direct reports.
• Perform other tasks and assignments as needed and specified by management.

Qualifications:

• An advanced degree (e.g., Masters, PhD, PharmD, M.D.) in scientific discipline and a minimum of 10 years progressively responsible, relevant experience in a pharmaceutical, biotechnology or related environment.
• Experience in managing more than one therapeutic area simultaneously.
• Experience Leading Therapeutic Area leads Senior MSLs and MSLs for at least 5 years.
• Experience in pre-launch, launch and pos launch orphan drug (preferably in neurology or metabolism)
• Hands-on experience supporting the registration and launch of an orphan, rare disease, and/or specialized drug(s) in the country/region of responsibility.
• In-depth, hands-on experience working with KOL's, clinicians, HCPs, payors, and/or academic institutions establishing/maintaining relationships and scientific/medical credibility.
• Demonstrated success in interpreting scientific data and presenting research information to scientists and HCPs.
• In-depth experience creating regional plans for a country orientation, while working within a regional/ global framework
• Experience dealing and working with Health Canada, Canadian government organizations including HTAs and other payers: CDA, INESSS, private payers.
• Experience interacting with patient organizations at the local level.
• Excellent working knowledge in local regulations and code of practice.
• Ability to influence without direct authority.
• In depth experience working with patient support programs
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and skills, including Scientific/technical writing and presentations including the ability to communicate complex technical information clearly.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• An analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills include the ability to support and prioritize multiple projects.
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
• Bilingual in French preferred

Travel requirements: 50% (national and international travel)

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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Originally posted on Himalayas

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