Medical Director, Clinical Development Bone Metabolism and Rare Endocrinology
Medical Director, Clinical Development Bone Metabolism and Rare Endocrinology
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Job Description
Medical Director Clinical Development Bone Metabolism and Rare Endocrinology
This is what you will do
The Medical Director may lead a clinical subteam or support the clinical subteam and the global program team to build global clinical development plans and develop assetlevel and therapeutic area strategies. Responsible for overseeing the clinical development strategy development and execution for one project 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 and before external audiences. May provide medical oversight to other younger less experienced Clinical Development Scientists.
You will be responsible for
Lead or support the clinical subteam and oversee the design execution read out and reporting of one or more clinical studies.
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 Clinical Development Scientists and/or fellows;
Lead a clinical subteam and prepare a clinical development strategy. May lead one or more clinical study teams in the preparation of clinical studyrelated 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 disease area and the competitive landscape and synthesise information succinctly to support dissemination and incorporation into clinical development programs asset plans and therapeutic area strategy.
Lead the clinical subteam and study/ies for a given program. Serve as the Medical input to the Global Dev Lead the clinical subteam and oversee studies within a program.
Serve as the Medical input to the Global Development Team / Subteam and the Medical Expert clinical study team development Team / Subteam and the Medical Expert for clinical study team.
Liaise internally with other clinical development team members (including ClinDev Scientists and Clinical Project Leads) to drive overall program strategy and development plans. Represent Clinical Development at the Global ProjectTeam.
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 boards experts
Working as part of a crossfunctional 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 PhD with Clinical Development experience;
>5 years of Development experience preferably within the industry (a minimum of 3 years of industry experience may be acceptable for outstanding candidates)
Experience as a medical monitor for clinical trials required
Regulatory experience preferred
Publication in peerreviewed 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 13 years
The duties of this role are generally conducted in an office environment. As is typical of an officebased 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 problemsolving and nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
Advanced knowledge of the assigned therapy area is desired (Internal medicine endocrinology rheumatology) with the capability to interpret discuss and represent trial or programlevel data.
Experience for medical responsibilities on a crossfunctional team preferred
Understanding of general (and specific) therapeutic principles
Experience designing and executing industrysponsored clinical trials
Broad experience in the principles of clinical trial methodology statistics data analysis and interpretation
Expertise in scientific literature searches and weighing of quality peer reviewed data
Experience authoring study essential documents Clinical Study Reports and regulatory documents
Ability to clearly communicate to internal and external stakeholders orally and in writing
Experience interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists etc.
Ability to prioritize multiple tasks and goals to ensure completion in a timely manner within budget
Ability to think both strategically and tactically
At Alexion you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients lives.
Ready to lead and inspire
Apply now and take the first step towards a fulfilling career at Alexion AstraZeneca Rare Disease.
Date Posted
09May2025Closing Date
22May2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.
Required Experience:
Director
Employment Type
Full-Time
