Country Medical Director, Canada
Canada
Development & Medical – 630 - Medical Affairs - G&A /
Full Time /
Remote
Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.
Position Summary
The Country Medical Director role is a hands-on role defining the medical strategy whilst executing and overseeing Canada Medical activities for Amicus Therapeutics.
Roles and Responsibilities:
- Define and implement the local medical strategy for the entire product portfolio developed by Amicus Therapeutics.
- Coordinate Medical Affairs activities to ensure the successful implementation of Action Plans and supporting Amicus Therapeutics clinical development activities.
- Deliver scientific and medical information to answer specific and documented questions from Healthcare Professionals (HCPs).
- Manage the Medical Affairs team developing and maintaining the expertise of all members for the therapeutic areas covered by Amicus Therapeutics.
- Contribute to the development of knowledge of the relevant products and disease areas, externally and internally.
- Ensure compliance of Medical Affairs activities to Amicus policies and procedures, as well as all local regulatory and legal requirements. Ensure that appropriate systems and SOP/processes are being followed to meet these requirements. Act as Local Contact for Pharmacovigilance (LCPPV)
- Interact and optimise relationships with Thought Leaders and other members of the medical community to assist in understanding current disease management issues and data gaps in in Amicus’ Therapeutic areas of interest.
- Encourage appropriate research collaborations with academic institutions in predefined Areas of Research Interests.
- Participate as an active and integral member of the Canada management team and the International Medical Leadership Team (IMLT).
- Compliance with all company and local regulations, alignment with local Code of Conduct, including adverse events, product complaints and pregnancy reports according to company procedures
- Medical Strategy:
- Define, develop and effectively implement the Canada medical strategy for products already marketed and for investigational agents in development.
- Represent Canada interests to the Global and International medical teams to guide the long-term strategy of the product portfolio.
- Be the preferred scientific and medical contact with external thought leaders, Patient Associations and National Regulatory authorities;
- Provide advice and scientific assistance to General Manager and other functions of Amicus.
- Under the supervision of the General Manager, and in collaboration with the Market Access department and regulatory affairs contribute to the development of National Reimbursement applications.
- Clinical Research:
- Define and implement, in conjunction with health authorities, risk management plans, Phase IV studies and cohort follow-up studies for registered products while ensuring compliance with the Company's ethics and interests.
- Contribute to the development of public-private partnerships or research partnerships, including coordinating the implementation of studies led by an external investigator (Investigator Initiated Studies).
- Medical Affairs:
- ·Participate in scientific events, national or international congresses, meetings organized by learned societies or foundations.
- Ensure compliance with Canada regulations for all oral and written scientific communications on products and their environment;
- Coordinate the implementation of initial and continuing scientific training modules, and the delivery of those trainings to Amicus Therapeutics employees including the sales team and validate the medical relevance of the commercial messages delivered at training sessions;
- Develop scientific projects, patient support programs, medical education programs and clinical studies in collaboration with experts in the diseases covered by Amicus gathered within Advisory Boards
- Respond promptly to requests for scientific and medical training;
- Where appropriate, write the medical part of the files for Regulatory Authorities, or any other Health Authority
- Medical Governance:
- Contribute to the drafting and implementation of procedures that govern the activities of the Medical Team;
- Comply with, and enforce, regulatory obligations;
- Comply with, and enforce, Amicus Therapeutics' regulatory obligations and procedures or scientific and medical information in response to HCP requests.
Requirements:
- Educational Requirements
- Higher Degree (MD/PhD) with a Medical Doctorate preferred
- Professional Work Experience Requirements
- Substantial experience with a leading international life science company within the biopharmaceutical/pharmaceutical industry
- Track record of success as Senior Medical Manager or Director, acquired in the field of Medical Affairs. Line management experience is a plus
- Must possess advanced understanding of the Canadian healthcare environment including governing laws and regulations including the IMC code
- Strong understanding of the wider health Care system including health technology assessment, regulatory processes and pharmacovigilance requirements
- Scientific and medical expertise in rare diseases, personalized medicine and innovative products. Prior expertise in Lysosomal Disorders a plus
- Demonstrated initiative and medical launch experience
- Thorough experience and confidence when positioning biologic products with selected Thought leaders and prescribing physicians and hospitals
- Experience in communicating and building relations with authorities, health care sector professionals including specialist care and sales, as well as Thought Leader management
- Strong track record in in delivering well defined and measurable results (plan vs. actual)
- International cultural awareness and orientation combined with excellent business acumen
- Experience in organizing scientific events and/or managing external experts KOLs management
- Good knowledge of research and clinical development
Experience and Skills
- Strong demonstration of, and role model for, Amicus Mission Focused behaviors
- Strategic vision and ability to simultaneously execute multiple projects involving rapid decision-making
- Good organization and adaptability
- Strong interpersonal skills
- Team player
- Takes responsibility
- Projects confidence and integrity
- Works well in ambiguous and challenging environments
- Respectful of cultural differences
- Strategic outlook with tactical capability
- A passion for helping patients with rare diseases
- Great scientific rigor
Other skills/Attributes
- Demonstrated alignment with Amicus Mission Focus Behaviors
- Passion for rare disease and patient focused
- Excellent English and native local language speaker
Travel
- Domestic and International travel required (40%)
Please note: This is not an exhaustive list of job responsibilities. A detailed job description will be provided during the application process.
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, colour, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.
