This is what you will do:

Reporting to the VP, Therapy Area Head of the Cell Therapy Platform, the incumbent may lead a clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contributeto the development of asset level and therapeutic area strategies. Responsible for overseeing the clinical development strategy development and execution for one or several projects, leading the clinical sub team to the GPT and represents clinical development on the GPT, contributing to the development of clinical & regulatory strategy, and representing the clinical program at regulatory meetings and before external audiences. May provide medical oversight2-3 Clinical Development Scientists and/or Medical Directors.

You will be responsible for: 

• Lead or support the clinical sub team and oversee the design and execution of one or two 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 sub team and prepare a clinical development strategy. May 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 advisoryboard 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 synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.

• Lead the clinical sub-team and study/ies for a given program. Serve as the Medical input to the Global Dev Lead the clinical sub-team and oversee studies within a program. 

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

• Liaise internally with other members of the clinical development team (including ClinDev Scientists and Clinical Project Leads) to drive overall program strategy and development plans. Represent Clinical Development at the Global Project 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 boards experts

• Working 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 (PharmD with Clinical Development experience); Board Certification preferred

• >5 years of clinical experience preferably within industry (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 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; 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:

• Advanced knowledge of the assigned therapy area (neurology and immunology) and the capability to interpret, discuss, and represent trial- or program-level data are desired.

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

• Understanding of general (and specific) therapeutic principles

• Experience designing and executing industry-sponsored clinical trials

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

• Exposure to Advanced Therapies in clinical practice, research or industry

• 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 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 prioritise multiple tasks and goals to ensure completion on time within budget

• Ability to think both strategically and tactically

Working at Alexion

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.

• We’re 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. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.