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.Clinical Development Sciences, Senior Medical Director (Bone Metabolism)Location: Barcelona/Boston/MississaugaReports To: Vice-President, TA Head Bone Metabolism and NF1 Clinical DevelopmentThis is what you will do:The Senior Medical Director (Bone Metabolism) will lead the clinical sub-team and the global program team to build global clinical development plans and contribute to developing asset-level and therapeutic area strategies.
Responsible for overseeing the clinical development strategy development and execution for one late-stage program, leading the clinical subteam to the GPT, representing clinical development on the GPT, contributing to the development of regulatory strategy, and being the clinical spokesperson at regulatory meetings.
May supervise up to 5 direct reports (Medical Directors for the program studies and/or Clinical Development Scientists), and 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 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; Lead a clinical subteam and oversee the preparation of a clinical development strategy.May lead one or more clinical study teams in preparing 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 teams.Liaise internally with other clinical development team members (including ClinDev Scientists, Clinical Project Leads or Biometricians) to drive overall program strategy and development plans.Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan.Support business development activities, such as due diligence and research collaborations.May serve as the Translational Science lead for one or more programs.Work as part of a cross-functional team with colleagues representing 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 (PharmD with Clinical Development experience); Board Certification preferred.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 accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought.
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