Associate Director Medical Affairs (France)

Associate Director Medical Affairs – France

Position Summary

Under the direction of the Medical Director, the Associate Director Medical Affairs (ADMA), France, for Pompe and Fabry diseases is responsible for developing and delivering a full range of Medical Affairs activities in France.

The ADMA will have already gained an excellent working knowledge and be able to provide examples of best practice in Medical Affairs. The ADMA will demonstrate the ability to take responsibility for delivering key medical affairs activities as described in the following section.

The ADMA will provide technical scientific consultation to both the medical, market access and commercial teams, ensuring accuracy and compliance with the Amicus standards and French rules and regulations. The ADMA will have a have a strong scientific / medical background and be able to converse at all levels.

Roles and Responsibilities

Associate Director Medical Affairs (ADMA), France, for Pompe and Fabry diseases, will provide support to the Medical Director in developing and implementing Medical Affairs’ initiatives to support the needs of the Affiliate including, but not limited to:

• Develop and implement comprehensive local Medical Affairs strategy and plan for Fabry and Pompe areas
• Support the Country Medical Director in Market Access activities in close collaboration with Market Access, Regulatory Affairs, Program Management, Global Medical Affairs and local functions
• Systematically identify and develop scientific collaboration and exchange in Pompe disease, while maintaining scientific collaboration and exchange in Fabry disease
• Serve as a central Amicus Medical Affairs representative for key stakeholders, providing deep and advanced disease state and product information as well as facilitating collaborations aligning with Amicus’ strategic goals
• Support the management of local Medical Affairs budget
• Development and implementation of national key medical events such as medical standalone meetings or symposia in close collaboration with key stakeholders
• Initiate and support high impact medical education activities including digital and virtual options
• Make an intelligent interpretation of key relevant scientific data, identify unmet medical, educational, and research needs within the medical community
• Provide medical input direction to the development of impactful scientific and medical education messages and materials
• Provide medical input to the production of key promotional material ensuring medical relevance and accuracy
• Spend time in the field (face-to-face and virtual) to provide appropriate and timely medical support to products
• Maintain knowledge of the respective therapeutic area, stay current on leading edge medicines and development efforts, attend appropriate national and international meetings and congresses to gather intelligence conduct routine literature searches, and communicate regularly to assure that the entire Medical Team benefits
• Represent a reliable, trusted, resource of accurate, up-to-date, medical, and scientific knowledge
• Initiate and support phase IV studies and registries development with protocol and CRF conception in collaboration with the CRO; Manage with the investigator sites the setting-up, monitoring and recruitment for these phase IV studies or registries, in conjunction with the CRO project manager. Contribute to the selection of local investigator sites for international clinical trials
• Stay current of local laws and guidelines, codes of practices and Amicus policies relevant to Medical Affairs activity. Ensure Compliance with current regulations and guidance of HCP interactions by developing and adapting according to internal procedures. Seek clarification from management and/or Compliance & Legal when uncertain whether a proposed activity could violate Amicus policy or the law
• Serve as main contact, together with the Medical Director, for audits in medical activities and responsibilities

The ADMA role entails not only deep scientific understanding and customer expertise, but also requires the ability to understand and effectively utilize scientific and operational resources to address the customer needs as well as internal requirements. It also requires profound project management, coordination, and organization skills.

Educational Requirements

• Medical (preferred) or scientific degree
• Post-graduate scientific degree would be an advantage (e.g. MPhil, MSc, PhD, MD)

Professional Work Experience Requirements

• Significant Medical Affairs experience with field experience, within biotechnology or pharmaceutical industry and a record of significant accomplishment
• AD/Senior Medical Advisor, AD/Senior Medical Manager, or similar with thorough understanding of the biopharmaceutical industry
• Good knowledge of national regulatory guidelines, Code of Practice and Standard Operating Procedures, and experience of their implementation within the business environment
• Track record as a final medical signatory
• Proven knowledge of Medical Affairs including clinical trial design, management, analysis, and reporting, including GCP
• Experience of at least one product launch, preferably in rare disease
• Ability to manage all aspects of Medical Affairs responsibilities on country level
• Demonstrated ability to evaluate medical/scientific literature accurately and effectively and develop effective medical and communication strategies
• Strong business acumen: has working knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g., research, development, clinical operations, biostatistics, regulatory, commercial

Experience and Skills

• Excellent verbal/written communication and listening skills
• Proven planning and organizational skills
• Proven ability to collaborate and make connections with both internal and external stakeholders
• Stellar interpersonal skills, customer focus and emotional intelligence in developing and maintaining professional relationships
• Thrives in a team environment
• Proven self-starter who is solution focused and positive when presented with challenges
• Ability to manage a demanding schedule and flexibility as needed with evolving priorities
• Clear alignment with Amicus Core Values
• Fluent in local language and in written and spoken English

Other skills/Attributes

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

Travel

• Some local and international travel required

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.

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