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.
Senior Medical Director, Clinical Development Sciences Location : Barcelona, ES
This is what you will do: The Senior Medical Director, Clinical Development Sciences may lead the clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contribute to the development of asset level and therapeutic area strategies. Responsible for overseeing the clinical development strategy development and execution for 1 program, leading the clinical subteam to the GPT and representing clinical development on the GPT, contributing to the development of regulatory strategy, and representing the clinical program at regulatory meetings. May supervise 1-2 direct reports (Medical Directors for the program studies and/or Clinical Development Scientists) or provide medical oversight.
You will be responsible for: Lead or support the clinical sub team and oversee the design and execution of multiple clinical studies or clinical programs.
Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee).
Supervise and develop Medical Directors and CDS and/or fellows; may lead a clinical subteam and oversee the preparation of a clinical development strategy.
Lead one or more clinical study teams in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
Determine appropriate advisory board experts and lead the team in preparation for meetings.
Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.
Lead the clinical sub team and oversee multiple studies for a given program.
Serve as the Medical input to the Global Development Team / Subteam and the Medical Expert for clinical study team.
Liaise internally with other members of the clinical development team (including ClinDev Scientists) to drive overall program strategy and development plans.
Represent Clinical Development at the Global Program Team.
Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
Support business development activities, such as due diligence and research collaborations.
May serve as the Translational Science lead for one or more programs.
Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.
Determine appropriate advisory board experts.
Work as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management.
May supervise other medical monitors on individual studies.
You will need to have: MD or equivalent.
Experience as a medical monitor for clinical trials required.
Regulatory experience preferred.
Publication in peer-reviewed journals.
Excellent written/oral communication skills.
Attention to detail and ability to think strategically.
Willingness to take on new responsibilities.
Interest and ability to learn about new therapeutic areas.
Interest in career progression and ability to take on more senior roles in 1-3 years.
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; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate.
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