Medical Director, Clinical Development Sciences

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.

Medical Director, Clinical Development Sciences

Location : Hybrid, Barcelona, Spain

This is what you will do : Seeking an individual who is Board Certified in Internal Medicine with 3-5 years of industry experience to work within the complement inhibition franchise. This individual will serve as a medical expert for the study team and medical monitor for phase 2-4 clinical trials. This position additionally offers substantial opportunities for regulatory and commercial interactions and career advancement in the fast-moving area of rare disease.

You will be responsible for :

• Medical Expert for clinical study team
• Protocol development from concept to final protocol
• Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring
• Strategic guidance to phase II/III development programs and oversight of global clinical trials/trial team (s) on assigned program(s)
• Presentation at academic congresses, investigator meetings and advisory meetings
• Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
• Data review

You will need to have :

• MD or equivalent
• History of industry or academic clinical or basic science research
• Excellent written / oral communication skills
• Ability to think strategically
• Willingness to take on new responsibilities
• Attention to detail
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have :

• Minimum 3-5 years of industry experience
• Previous clinical trial experience as medical monitor in industry setting
• Safety medical monitoring and reporting experience
• Protocol development experience
• Understanding of regulatory requirements related to clinical trials
• Basic statistical knowledge
• Subspecialty certification
• Board Certification
• Business development experience
• Publication in peer reviewed journals

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.