Senior Director, Regional Medical Lead, International, Pompe

Senior Director, Regional Medical Lead, International, Pompe

Amicus Therapeutics

Marlow, United Kingdom

SUMMARY OF POSITION

The Senior Regional Medical Lead (RML) is the senior medical director for the international region exclusively dedicated to Pompe Disease.

This is a strategic medical leadership position that role models partnership with the Global Medical Lead, and Country Medical Directors to develop the medical plans for novel therapeutic products for patients with Pompe Disease and ensures the implementation and alignment of medical activities across the International.

As an MD/Pharmacist/PhD with experience in global, regional, and local medical affairs, the Senior RML will play a key role in developing and executing our wider vision for medical affairs. The Senior RML will stand-in for the Vice President, International, Medical at key internal governance meetings, on an ad-hoc basis.

The Senior RML supports the Global Medical Lead to establish the Global Medical Strategic Imperatives for products in Pompe Disease. In addition, the Senior RML will work collaboratively with Global Medical Operations and Country Medical teams to deliver post approval data generation (IIPs and Phase IV and non-interventional studies) and local publication plans.

The Senior RML will ensure that medical activities delivered across the region are aligned to the overall Global Strategy and objectives in Pompe Disease. The Senior RML will assist the international market access team in Global Value Dossier creation and national reimbursement submissions.

The Senior RML will ensure the Country Medical Team are adequately skilled to understand the unmet needs, disease, and product related data, and will work alongside Country Medical Directors to ensure the compliant implementation of above country and in country medical affairs projects.

The Senior RML will be responsible for establishing and maintaining appropriate working relationships with external Global and National Neuromuscular Thought Leaders, Pompe Research Institutions, Patient Advocacy Organizations, Regulators and Payers.

The Senior RML directly supervises the International Associate Director, Medical Affairs, Pompe and other Amicus Therapeutic employees or contract service staff supporting execution of International medical activities. The Senior RML may mentor other medical colleagues including Regional Medical Leads, or Country Medical Directors.

ROLES AND RESPONSIBILITIES

• Responsible for the development and execution of the medical activities within the International Medical Plan and supporting in country medical activities when needed;
• Ensured the medical activities are aligned to the Global Medical Strategy for the disease area and product(s);
• Accountable to deliver the clinical and scientific input from the International Region into the development of plans at the Global and International Launch Team, Global Pompe Publication Planning Team, Global Pompe Medical Matrix Team, Pompe Core, and to the Pompe Steering Committee on an adhoc basis;
• Partners with the International Commercial operations Leadership Team (ICOLT) to support affiliate deliverables and ensure alignment against strategy;
• Proactively cascades decisions from Governance meetings to the International Medical team and other cross functional teams;
• Elevate and cascade key insights from medical interactions in the field and formal advice seeking;
• Develop and lead International scientific educational programs and events for healthcare providers in partnership with cross functional teams;
• Develop and lead International scientific advice seeking events, coordinating insights from the field, and sharing where appropriate;
• Support Global scientific advice seeking events;
• Establish networks with external experts in Pompe Disease to expand potential research opportunities aligned with the Global Medical Strategy and Key Areas of Interest and seek medical insights to inform local and regional strategy;
• Support Global Medical Operations and Country Medical Teams to deliver post approval data generation activities including investigator-initiated research and company sponsored phase IV and or non-interventional research;
• Co-lead and develop concept outlines for Phase IV national observational, non-interventional company and collaborative research;
• Co-lead with cross functional partners the development and execution of a Digital Strategy for Pompe across the International Region;
• Responsible for the clinical and scientific training in Pompe including disease and product related training events for the country medical teams;
• Deliver presentations at relevant internal meetings and support international training to develop high level of medical knowledge across Amicus Therapeutics;
• Develop, communicate, and maintain in-depth scientific knowledge of Amicus Therapeutics products and pipeline and other products in related therapeutic areas;
• Ensure accurate and timely medical advice on Amicus Therapeutic products to healthcare professionals with the assistance of the Country Medical teams as appropriate;
• Provide clinical and scientific input into Country Brand plans and Business Reviews;
• Ensure that all the activities of the team are conducted in a fully compliant manner in accordance with Amicus policies and country laws and regulations;
• Manage the Medical Affairs budget for Pompe Disease at a regional level;
• Provide clinical and scientific input into the national reimbursement dossiers;
• Provide Final Medical Review of scientific and promotional materials/activities, where appropriate and ensure adherence to National Codes (including ABPI), Laws and Regulations;
• Identify, select, and manage preferred external vendors to support medical affairs deliverables.

ORGANIZATIONAL STRUCTURE

• Reports to Vice President, International, Medical;
• Directly supervises Associate Director, Medical Affairs, International.

QUALIFICATIONS AND BACKGROUND REQUIREMENTS

Educational Requirements:

• Higher Degree (MD/Pharmacist/PhD);
• Higher Medical Qualification (example of MRCP) and Diploma in Pharmaceutical Medicine an advantage.

Professional Work Experience:

• Experienced medical director from a leading international life science company within the biotech/biopharmaceutical/pharmaceutical industry. Prior experience in biotech preferred;
• Prior experience in orphan drugs and rare diseases a distinct asset;
• Prior experience of Respiratory, Neurology or Neuromuscular Medicine an advantage;
• Proven history of launching a new medicine (small molecule and/or biologic) and executing International or Global Medical Affairs activities is crucial. For example, leading Regional Advisory Boards, International Scientific Symposium, company sponsored research initiatives and publications planning;
• Proven history of supporting European/International Country launches;
• Proven history of collaborating with key cross functional partners including Country Medical and Commercial teams and Global Medical and Marketing, Market Access, Patient Advocacy, Legal & Compliance, and R&D;
• Recent examples of implementing digital communications to overcome healthcare challenges are a distinct advantage;
• Significant experience as a final ABPI Medical Signatory (PMCPA) and champion of medical governance, along with other national regulations;
• Thorough experience and confidence when communicating with Global and National Experts in the desired therapeutic area or related areas;
• Experience in communicating and building relations with the wider health care sector professionals;
• Orphan Drug experience desirable.

Required attributes:

• A passion for helping patients with rare conditions;
• Demonstrates Amicus Core Values;
• Excellent leadership skills, with proven experience of leading a team;
• Autonomy, self-motivation, and efficiency, with an appropriate sense of urgency in a fast-paced and dynamic environment whilst working at times with ambiguity;
• Strong organizational skills with the ability to prioritize and manage multiple time-sensitive projects simultaneously;
• Strong verbal and written skills with ability to explain complex, challenging issues in a clear manner to all levels of the organization, especially senior management;
• Strong people skills, including diplomacy and flexibility, and the ability to engage and influence effectively with key stakeholders;
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams);
• Strong communication and presentation skills;
• Fluent in English Written and spoken, second language such as French, Spanish, German would be an advantage.

Travel:

• International travel will be required (up to 20%).

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