Manager, Medical Affairs - Iberia (Spain & Portugal)

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/s area/s. In particular, Orchard is the MAH of Libmeldy, an ex vivo gene therapy product for Metachromatic Leukodystrophy for which it has just obtained reimbursement in Spain, and is developing other ex vivo HSC-GT products for other neurometabolic diseases, including Mucopolysaccharidosis IH, known as Hurler's disease, and other serious rare diseases.

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

Key Elements and Responsibilities

To include but not limited to:

• develops and execute the local medical affairs plan for Orchard’s products, and manage associated budget;

• develops a proper advocacy plan and engagement with national KOLs;

• releases scientific trainings to internal colleagues;

• defines the medical context and reviewing promotional materials;

• cooperates with other Departments (Regulatory, Market Access, Pharmacovigilance) in the preparation of relevant documents necessary to meet the requirements of local Health Authorities;

• supports/investigates life cycle management initiatives for the products;

• provides timely and audience-appropriate information and updates to enhance the understanding of the scientific and medical value of Orchard’s clinical programs;

• maintains training records and delivers training updates to ensure all assigned Qualified Treatment Centers personnel are appropriately trained according to the Product Manual;

• develops a territory profile including Centers of Excellence, key expertise, newborn screening approaches and leaders, and market access pathways to inform medical strategy and tactical planning in collaboration with appropriate cross-functional partners;

• supports clinical science and clinical operations in building and maintaining key clinical trial site relationships as needed;

• reviews and oversees Investigator-Sponsored Study/Trial (ISS/IST) requests and Early Access Program (EAP) requests throughout the internal review process and any follow up requests for information;

• represents Medical Affairs on key cross-functional internal teams as needed;

• demonstrates therapeutic area expertise, clear business understanding and industry experience to identify and address the relevant medical needs of clinical practice, to successfully support the optimal use of Orchard’s products;

• maintains high standards of compliance, ethics and safety of Orchard’s products, putting patients at the centre of his/her actions;

• demonstrates expert knowledge and understanding of the marketed and pipeline products to be able to respond to queries, train internal & external stakeholders & influence & shape the strategic direction of the therapy area;

• leads non-promotional activities at scientific congresses, including but not limited to: abstract submissions, educational symposia, insight gathering and post-conference debriefing to internal colleagues;

• reports adverse events associated with the use of Orchard’s marketed products to the Pharmacovigilance team as per company SOPs;

• other responsibilities as assigned.

Requirements

Required Knowledge & Experience

• Track record of successfully establishing relationships with health care provider thought leaders and extended clinical care teams to become a preferred point of contact and trusted resource;
• understanding of country level government and industry guidelines, regulations, laws, etc., for appropriate and compliant exchange of scientific and clinical information with external stakeholders;
• experience and relevant knowledge in one or more key therapeutic areas (hematopoietic stem cell transplantation, gene therapy, neurology, lysosomal storage disorders, neuro metabolic diseases preferred) and in ATMP/gene therapy;
• experience in developing and delivering effective scientific educational materials and programs;
• knowledge and established network with health care providers and industry experts;

·         fluency in both spoken and written English as well as local country languages (Spanish essential/Portuguese & Italian desirable).

Skills & Abilities

• 3-5 years of Medial Affairs experience with external facing stakeholder engagement within the biotechnology or pharmaceutical industry;
• effective communication skills regarding complex clinical and scientific information;
• team working skills;
• highly collaborative and passionate personality;
• growth mindset: curious by nature, proactive in keeping abreast of key scientific developments and building understanding of assigned territory;
• valid Driver’s License and clean driving record;
• ability to travel frequently (50%), often overnight.

Education

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