Manager, Medical Affairs - Iberia (Spain & Portugal)

Orchard Therapeutics; Madrid; Presencial; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

A leading biotechnology company is seeking a Manager for Medical Affairs in Spain. The role involves developing medical strategies, engaging with key opinion leaders, and ensuring compliance with regulations. The ideal candidate will have a strong background in gene therapy and experience in stakeholder engagement.

Formación

• 3-5 years of Medical Affairs experience in biotech or pharma.
• Fluency in English and Spanish; Portuguese and Italian desirable.
• Experience in gene therapy or hematopoietic stem cell transplantation.

Responsabilidades

• Develop and execute the local medical affairs plan for Orchard’s products.
• Create advocacy and engagement strategies with national KOLs.
• Collaborate with Regulatory and Market Access teams.

Conocimientos

Stakeholder Engagement

Scientific Communication

Teamwork

Proactive Mindset

Educación

Advanced scientific or healthcare degree (MD, PhD, PharmD, NP, DVM, CGC)

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 lives through innovative cell and gene therapies for rare diseases. Headquartered in London with U.S. operations in Boston, it is a wholly owned subsidiary of Kyowa Kirin, Japan.

The Manager, Medical Affairs (MM), is a scientific expert in therapeutic and disease areas, providing medical and scientific support to internal teams and external stakeholders for Orchard’s products and activities. Orchard is the Marketing Authorization Holder (MAH) of Libmeldy, an ex vivo gene therapy for Metachromatic Leukodystrophy, recently reimbursed in Spain, and is developing other ex vivo HSC-GT products for neurometabolic diseases, including Hurler's disease and other rare conditions.

Key Responsibilities

1. Develop and execute the local medical affairs plan for Orchard’s products, managing the budget.
2. Create advocacy and engagement strategies with national KOLs.
3. Provide scientific training to internal teams.
4. Define medical context and review promotional materials.
5. Collaborate with Regulatory, Market Access, and Pharmacovigilance teams on documentation for local authorities.
6. Support lifecycle management initiatives for products.
7. Provide timely, audience-appropriate scientific updates to enhance understanding of Orchard’s clinical programs.
8. Maintain training records and ensure personnel at Qualified Treatment Centers are trained per the Product Manual.
9. Develop territory profiles, including centers of excellence, expertise, screening approaches, and market access pathways, in collaboration with cross-functional teams.
10. Support clinical science and operations in building and maintaining key clinical trial site relationships.
11. Review Investigator-Sponsored Study/Trial requests and Early Access Program requests.
12. Represent Medical Affairs on cross-functional teams.
13. Demonstrate therapeutic expertise and industry experience to address medical needs and support product use.
14. Ensure high standards of compliance, ethics, and safety, prioritizing patient welfare.
15. Maintain expert knowledge of products to respond to queries, train stakeholders, and influence strategy.
16. Lead non-promotional activities at scientific congresses, including abstract submissions and educational symposia.
17. Report adverse events related to Orchard’s products to Pharmacovigilance as per SOPs.
18. Perform other duties as assigned.

Required Knowledge & Experience

• Proven ability to establish relationships with healthcare providers and thought leaders.
• Knowledge of country-specific regulations and guidelines for scientific exchange.
• Experience in therapeutic areas like hematopoietic stem cell transplantation, gene therapy, neurology, lysosomal storage disorders, or neuro-metabolic diseases, especially ATMP/gene therapy.
• Experience in developing scientific educational materials and programs.
• Established network with healthcare providers and industry experts.

Fluency in English and Spanish is essential; Portuguese and Italian are desirable.

Skills & Abilities

• 3-5 years of Medical Affairs experience with external stakeholder engagement in biotech or pharma.
• Effective communication of complex scientific information.
• Strong teamwork and collaboration skills.
• Proactive, curious, and growth-oriented mindset.
• Valid driver’s license and ability to travel up to 50%, often overnight.

Education

Advanced scientific or healthcare degree (MD, PhD, PharmD, NP, DVM, CGC, or similar); RN, MS, or equivalent with substantial experience also considered.