Senior Medical Affairs Manager @ Amicus Therapeutics

  • TypeFull Time
  • RoleNon-Clinical
  • SectorNon-Clinical
  • SeniorityNon-Leadership
  • LocationUK

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

This role works as a member of the International Headquarters Medical Affairs team, and will provide, and where appropriate, lead, technical scientific consultation to both the medical, market access and commercial teams, ensuring accuracy and compliance with the Amicus standards and Country rules and regulations. As a final ABPI medical signatory, they will have a have a strong scientific / medical background and be able to converse effectively all levels.

In addition to the above the role will be responsible for:

  • Thought Leader Engagement
    • Develop and maintain excellent thought leader relationships in conjunction with the broader country team
    • Lead and support the delivery of Advisory Boards
    • Regularly attend events such as scientific meetings, conferences/symposia to interact with thought leaders and enhance disease area knowledge whilst also ensuring high quality feedback is provided in a timely manner to relevant colleagues
    • Organise and run high quality medical education meetings & initiatives
    • Support Amicus’ vision and goals through regular meetings with physicians and other key customers
  • Medical Information and Communication
    • Support Medical Information enquiry handling process and advise on medical safety or clinical issues as required
    • Lead and support congress medical information activities
    • Provide literature analysis for Key Account Managers (KAMs), marketing, and customers
    • Ensure adverse events and pregnancy reports are duly processed in line with company procedures and assist in assessment of adverse event reports originating in the Country for completeness, consistency, and reporting requirements
  • Medical oversight and review of promotional and non-promotional activities
    • Apply good working knowledge of country Codes of Practice such as ABPI/IPHA, and Amicus Standard Operating Procedures (SOP) and advise on compliance issues and review promotional materials and activities
    • Ensure compliance with SOPs, GCP, GMP and ICH as well as legal and ethical standards
  • Medical Training
    • Create and deliver effective Medical training and clinical updates
    • Develop slide decks for training activities and for the support of key customers
    • Demonstrate expert knowledge of Amicus’ and competitor products and activities
  • Clinical Trial activity
    • Contribute to the management of Investigator Initiated Studies (IIS)
    • Lead and contribute to the selection of potential study sites for development trials
    • Provide strategic input into the development and execution of local clinical trials, IIS activities and publication plans

Requirements

Educational Background and Professional Work Experience

  • Experienced Medical Affairs professional, with proven track record in delivery of key activities such as Advisory Boards, Medical Education event and medical plan development
  • Experienced as a ABPI medical signatory
  • MD or UK-registered pharmacist
  • Experience in rare diseases would be an advantage
  • Experience working above-country would be an advantage
  • Experience in health economics and market access is desirable

Skills

  • Able to communicate with credibility, impact and influence
  • Advanced scientific & medical reading and writing skills
  • Strong stakeholder management skills
  • Proactive self-starter with a high level of initiative and persistent
  • Solid customer orientation and patient centricity
  • Science-based yet commercially aware
  • Fluent in written and spoken English
  • Proven project management skills

Other Skills/Attributes

  • Demonstrated alignment with Amicus Mission Focus Behaviors
  • Passion for rare disease and patient focused

Travel

  • Some local and international travel will be required (10-15%)

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.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, 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.