Munich, Bavaria, Germany
The Regional Medical Affairs Director will provide medical support for the pre and post approval gene therapies in the EMEA region. He/she will work closely with a cross-functional group that includes Clinical Development, Market Access, Commercial, Regulatory, and Corporate Communications as well as the Global Medical Affairs to ensure that scientific and medical strategies are aligned with broader corporate, commercial and patient needs. This is a great opportunity to join a growing EMEA medical affairs team and have an input in the growth strategy.
Key Elements and Responsibilities to include but not limited to:
• Accountable for supporting the Head of Operations Medical Affairs in the development, implementation and execution of the Global Medical Affairs Strategy and plan for pipeline and post approval products
• Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development and marketed therapies; review clinical trials and local grants, as needed.
• Partners with KOLs to provide insights on current focused therapeutic area issues and questions
• Provides input and contributes to the global Medical Affairs objectives and tactics.
• Support Regulatory, PV/MI, Clinical Research and health economics teams in medical scientific questions
• Internal and external presentations to enhance the medical knowledge of development projects and marketed products
• Ensures that marketing functions have appropriate medical scientific support
• Reviews promotional materials in the respective area according to the company SOP
• Provide medical input and guidance to Early Access Programs and individual IND (early access) requests.
• Keeps product and development project information up to date based on internal and external publications
Possess understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers.
Experience in Medical Affairs within the biotechnology or pharmaceutical industry
Experience with product launches and life-cycle management
Ability to develop internal relationships in a highly matrixed environment, as well as external relationships with Key Opinion Leaders and industry experts
Excellent strategic skills with the ability to influence decisions, both internally and externally
Ability to travel to meetings/trainings/programs etc as required
Skills & Abilities
Engaged, dynamic, results-driven
Strong team work skills, ability to get results in a cross-functional setting, and enjoys operating in a highly motivated team environment
Good strategic thinking and business Acumen
Ability to assimilate new information and to interpret and inform the business
Ability to manage multiple projects simultaneously
• Medical Degree
• Fluency in both spoken and written English
• Experience in Rare Diseases, Bone Marrow Transplantation, Gene/Cellular Therapy is desirable
Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.