Associate Medical Director Clinical Development Nephrology

The Associate Medical Director Clinical Development Nephrology may lead the clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contributes 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 represents clinical development on the GPT contributing to the development of regulatory strategy and representing the clinical program at regulatory meetings as assigned by manager.

What You Will Do

• Lead or support the clinical subteam 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.

• Functionally supervise and develop medical monitors and/or clinical development scientists (CDS) if any and as assigned by the manager.

• 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 as assigned by manager.

• Development of medical content for regulatory document and responses (including but not limited to NDAs/BLAs sNDAs/SBLAs briefing packages and common technical documents

• Determine appropriate external experts for advisory boards steering committees adjudication committees and/or data monitoring committees 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.

• Serve as the Medical input to the Global Development Team/Subteam and the Medical Expert for clinical study team.

• Conduct medical monitoring activities during periods of vacations team restructuring team departures or in other situations as assigned by manager.

• Lead the presentation of clinical trial related information/data to senior management as assigned by manager.

• Liaise internally with other members of the clinical development team 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 as assigned by manager.

• May serve as the Translational Science lead for one or more programs as assigned by manager.

• Working as part of a cross-functional team with colleagues representing biostatistics data management clinical pharmacology commercial regulatory safety quality and project management or others as assigned by manager..

• Lead Pediatric Program Design and Execution if applicable and as assigned by manager.

• Be accountable for the overall integrity of the data in the clinical trial.

Who You Are

• Physician with MD or foreign equivalent

• 3-5 years of clinical development experience preferably within industry

• 3-5 years minimum experience as a medical monitor for clinical trials required

• Regulatory experience preferred

• Track record of publication in peer reviewed journals preferably first-authored publications

• 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

• 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 with others; maintain general availability during standard business hours

We would prefer for you to have

• Clinical specialty certification from US or foreign equivalent

• Preferred: Advanced knowledge of the assigned therapy area is desired with the capability to interpret discuss and represent trial or program level data.

• 3 years of industry experience in clinical development is preferred

• Experience for medical responsibilities on a cross-functional team preferred

• Formal training (certificate or graduate degree) in epidemiology clinical trials clinical research biostatistics is strongly preferred

• Broad experience in the principles of clinical trial methodology statistics data analysis and interpretation

• Understanding of general (and specific) therapeutic principles

• Experience designing and executing industry-sponsored clinical trials

• Expert in scientific literature searches and weighing of quality peer reviewed data

• Experience authoring study essential documents Clinical Study Reports and regulatory documents

• Strong relevant therapeutic area experience

• 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.

• Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a companys drug development process e.g. clinical operations biostatistics regulatory commercial operations etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results

• Ability to prioritize multiple tasks and goals to ensure completion in a timely manner within budget

• Ability to think both strategically and tactically

• Advanced knowledge of the assigned therapy area is desired with the capability to interpret discuss and represent trial or program level data

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.

Working at Alexion

• Were inspired to think differently to create better outcomes. By creating an unparalleled employee experience our organization is equipped to adapt and enrich employees with a productive engaging and enjoyable work experience while accelerating world-class leadership and innovation capabilities that can deliver on our mission. Each of us is accountable for delivering innovative medicines and supportive technology with integrity so we can truly understand and better the lives of people affected by rare diseases. Together we can transform lives every day

  The Highest Standards

  By operating with the highest standards of ethics and integrity we aspire to live up to the expectations of patients physicians and ourselves and to earn trust in our communities.

  Diversity

  We encourage diversity of backgrounds and ideas. We genuinely care for and respect each other working together as a high-performing team to deliver extraordinary results while embracing different perspectives.

  Dedication

  The dedication and passion of our employees enable us to stay focused on what matters most. We push ourselves to achieve the highest level of medical innovation and to redefine what it means to live with a rare disease.

  In-Office Hybrid

  This role has an expectation of working in the office 3 days a week. When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.