Social network you want to login / join with :
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
Executive Medical Director
Location : Barcelona, Spain
Reports To : Vice President, Clinical Development, Neurology, Alexion
This is what you will do :
The Executive Medical Director is responsible for overseeing multiple programs, providing oversight, guidance, and mentoring to Medical Directors and Clinical Development Scientists. The role involves serving on strategic teams, supporting development of regulatory and therapeutic area strategies, and managing teams including Senior Directors and Medical Directors.
You will be responsible for :
- Leading 2+ program teams and driving clinical studies, research strategies, and benefit-risk management of products.
- Representing Clinical Development on global teams and at management review committees, interpreting data, and understanding the impact of therapies on rare and orphan diseases.
- Fostering development of Medical Directors, CDS, and fellows; overseeing clinical development strategies, protocols, and regulatory documents.
- Providing scientific and medical input to R&D, commercial, and business development functions, supporting due diligences.
- Representing Alexion Clinical Development to internal and external stakeholders, including academic, regulatory, and medical communities.
- Overseeing clinical components of the Clinical Development Plan (CDP), serving as the medical expert for clinical study teams, and contributing to regulatory submissions.
- Coordinating communication among medical functions related to clinical study design, execution, and results interpretation.
- Staying informed of scientific, clinical, regulatory developments through conferences, literature review, and competitive intelligence.
- Supporting business development activities, such as due diligence and research collaborations.
- Evaluating disease information and competitive landscape to support clinical programs and strategies.
- Managing advisory board experts and working with cross-functional teams including biostatistics, regulatory, and commercial teams.
- Supervising medical monitors on individual studies as needed.
You will need to have :
7+ years of experience in clinical development, including clinical research, regulatory, and product development.Experience with regulatory meetings with FDA and other agencies.Proven ability to design and execute multinational clinical trials.Leadership skills in defining clinical strategies and study design.#J-18808-Ljbffr