Senior Regional Medical Advisor, UK and Ireland (AD level)

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

Under the direction of the Country Medical Director, this position is responsible for developing and delivering a full range of Medical Affairs activities in the UK and Ireland.

Roles and Responsibilities

• Provide support to the Country Medical Director in developing and implementing Medical Affairs’ initiatives to support the needs of the Affiliate including, but not limited to:
  • Develop and maintain excellent thought leader relationships in the field of rare disease specifically Fabry Disease and Pompe Disease.
  • Take accountability for the development, oversight and execution of the medical plan in partnership with the Country Medical Director.
  • Provide technical scientific consultation to both the medical, market access and commercial teams, ensuring accuracy and compliance with the Amicus standards and UK and Irish rules and regulations.
  • Support the Medical Director with the execution of the Medical Affairs strategy and support country marketing activities for all Amicus products, ensuring adherence to all Amicus policies and procedures as well as local regulatory, legal and compliance requirements.
  • Provide operational support for activities related to Medical Information and Communication, Medical Education and Training, Clinical Trials (CTs) and Clinical Development support as needed.
  • Develop & deliver Health Technology Assessment submissions working in partnership with market access colleagues where required. Provide support to cross functional team members developing local programs and materials.

Additional Responsibilities

Note: the following percentages are an approximate guide to the allocation of time in each activity.

• Thought Leader Engagement (~40%)
  • Develop and maintain excellent thought leader relationships in conjunction with the broader country team.
  • 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 (~15%)
  • Supports Medical Information enquiry handling process and advises on medical safety or clinical issues as required.
  • 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 (~25%)
  • Applies expert working knowledge of country [ABPI/IPHA] Codes of Practice and Amicus Standard Operating Procedures (SOP) and advises on compliance issues and review promotional materials and activities.
  • Ensure compliance with SOPs, GCP, GMP and ICH as well as legal and ethical standards.
  • Role models a compliance culture within the business.
• Data generation and Clinical Trial activity (~10%)
  • Lead on the ideation and delivery of local evidence generation plans in areas of responsibility.
  • Lead local management of Investigator Initiated Studies (IIS).
  • Lead local 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.
• Medical Training (~10%)
  • 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.

Educational Requirements

• GMC registered Physician or Pharmacist with UK registration.
• Advanced post graduate scientific degree (MSc, MD, PhD) or health care professional.

Professional Work Experience Requirements

The successful candidate will have already gained an excellent working knowledge and be able to provide examples of best practice in Medical Affairs. They will demonstrate the ability to take responsibility for delivering key medical affairs activities; including but not be limited to running advisory boards, producing medical materials and medical education initiatives, delivering training, scientific symposia, data generation, publication work and maintaining a network of medical thought leaders. Where appropriate they will take a leading collaborative role in delivering health technology assessment submissions.

Excellent knowledge of appropriate national regulatory guidelines, e.g. Medicines Act and the Human Medicines Regulations, ABPI/IPHA Code of Practice and Standard Operating Procedures, combined with implementation within the business environment.

Strong track record of Material review as an experienced Final Signatory.

Prior experience as a Medical Advisor or MSL.

Small Biotech industry experience preferred.

Experience in rare diseases would be an advantage – ideally in lysosomal disorders.

Proven knowledge of medical affairs activities including clinical trial design, management, analysis, and reporting, including GCP.

If a Healthcare professional, proven clinical experience.

Experience and Skills

• Strong customer focus & a timely results oriented approach to their role.
• Must possess a good understanding of the healthcare environment in the UK and Ireland.
• Have a strong scientific / medical background and be able to converse on science and data at all levels.
• Experience in supporting clinical studies (phase III-IV, registries, investigator-initiated studies).
• Strong organisational, problem solving, and able to collaborate and work effectively cross functional working skills.
• Excellent interpersonal & team working skills.
• Excellent Project and time management skills.
• Sociable, confident, and outgoing.
• Fluent in local language and in written and spoken English.

Other skills/Attributes

• Demonstrated alignment with Amicus Mission Focus Behaviours.
• Passion for rare disease and patient focused.
• Good team player.

Travel

• Willingness to travel.

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We value an inclusive environment where individual experiences and perspectives are celebrated, and voices from the rare disease community are heard.

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.

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