Manager, Medical Affairs - Iberia (Spain & Portugal)

Orchard Therapeutics - U.S.; Madrid; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

A leading biotechnology company is seeking a Manager for Medical Affairs in Spain. This role involves providing scientific support, developing medical strategies, and engaging with healthcare stakeholders to promote innovative gene therapies. The ideal candidate will have a strong background in medical affairs, excellent communication skills, and the ability to build relationships within the healthcare community.

Formación

• 3-5 years of Medical Affairs experience with external stakeholder engagement.
• Fluency in English and Spanish; Portuguese and Italian desirable.
• Experience in gene therapy and related therapeutic areas.

Responsabilidades

• Develop and execute local medical affairs plan and budget.
• Engage with national KOLs and provide scientific training.
• Collaborate with Regulatory and Market Access departments.

Conocimientos

Relationship Building

Communication

Teamwork

Proactive Mindset

Educación

Advanced Scientific/Healthcare Degree (MD, PhD, PharmD, etc.)

Descripción del empleo

Reporting to

Senior Director, Medical Affairs - EMEA

Location

Spain

Job Summary

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative cell and gene therapies. Orchard has its global headquarters in London and its U.S. headquarters in Boston and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

The Manager, Medical Affairs (MM) is a therapeutic and disease area scientific expert who provides medical and scientific support to internal and external stakeholders for products and disease-related activities in Orchard's therapeutic areas. Orchard is the MAH of Libmeldy, an ex vivo gene therapy product for Metachromatic Leukodystrophy, recently reimbursed in Spain, and is developing other ex vivo HSC-GT products for neurometabolic diseases, including Mucopolysaccharidosis I (Hurler's disease), among others.

The primary purpose of this role is to communicate scientific and clinical findings to external audiences, foster understanding of Orchard's products and disease areas among healthcare stakeholders, and support the adoption of Cell & Gene Therapy solutions to address patient needs.

Key Elements and Responsibilities

To Include But Not Limited To

• Develop and execute the local medical affairs plan for Orchard's products, managing the associated budget.
• Develop advocacy plans and engage with national KOLs.
• Provide scientific training to internal colleagues.
• Define the medical context and review promotional materials.
• Collaborate with Regulatory, Market Access, Pharmacovigilance departments for document preparation.
• Support lifecycle management initiatives for products.
• Provide timely, audience-appropriate scientific updates.
• Maintain training records and ensure personnel at Qualified Treatment Centers are trained per the Product Manual.
• Develop territory profiles to inform medical strategy, including Centers of Excellence and market access pathways.
• Support clinical science and operations in building relationships with clinical trial sites.
• Review Investigator-Sponsored Study/Trial requests and Early Access Program requests.
• Represent Medical Affairs on internal teams as needed.
• Demonstrate therapeutic expertise and industry experience to support Orchard's products.
• Maintain high standards of compliance, ethics, and safety.
• Respond to queries, train stakeholders, and influence strategic directions.
• Lead non-promotional activities at scientific congresses.
• Report adverse events as per SOPs.
• Other responsibilities as assigned.

Requirements

Required Knowledge & Experience

• Proven ability to build relationships with healthcare providers and clinical care teams.
• Understanding of government and industry guidelines, regulations, and laws.
• Experience in key therapeutic areas such as hematopoietic stem cell transplantation, gene therapy, neurology, lysosomal storage disorders, neuro metabolic diseases, and ATMP/gene therapy.
• Experience in developing scientific educational materials and programs.
• Network with healthcare providers and industry experts.
• Fluency in English and local languages (Spanish essential; Portuguese and Italian desirable).

Skills & Abilities

• 3-5 years of Medical Affairs experience with external stakeholder engagement.
• Effective communication of complex scientific information.
• Teamwork and collaboration skills.
• Proactive, growth-oriented mindset.
• Valid Driver's License and ability to travel frequently (50%).

Education

Advanced Scientific/Healthcare Degree (MD, PhD, PharmD, NP, DVM, CGC or similar preferred; RN, MS, or similar with substantial experience considered).